Devices and methods for performing a vascular anastomosis

ABSTRACT

A system for performing an end-to-side vascular anastomosis, including an anastomosis device, an application instrument and methods for performing a vascular anastomosis. The system is applicable for performing an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly in port-access CABG surgery. A first aspect of the invention includes a vascular anastomosis staple. A first configuration has two parts: an anchor member, forming the attachment with the target vessel wall and a coupling member, forming the attachment with the bypass graft vessel. The anastomosis is completed by inserting the coupling member, with the graft vessel attached, into the anchor member. A second configuration combines the functions of the anchor member and the coupling member into a one-piece anastomosis staple. A second aspect of the invention includes an anastomotic fitting, having an inner flange over which the graft vessel is everted and an outer flange which contacts the exterior surface of the target vessel. A tailored amount of compression applied by the inner and outer flanges grips the target vessel wall and creates a leak-proof seal between the graft vessel and the target vessel. A third aspect of the invention has a flange to which the graft vessel attaches, by everting the graft vessel over the flange, and a plurality of staple-like members which attach the flange and the everted end of the graft vessel to the wall of the target vessel to form the anastomosis.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of co-pending application Ser.No. 09/166,338, which is a Divisional of Ser. No. 08/789,327, filed Jan.23, 1997, which is a divisional of application Ser. No. 08/394,333,filed Feb. 24, 1995, now issued as U.S. Pat. No. 5,695,504. The completedisclosures of the forementioned related U.S. patent applications arehereby incorporated herein by reference for all purposes.

FIELD OF INVENTION

[0002] The present invention relates generally to devices and methodsfor surgically performing an end-to-side anastomosis of hollow organs.More particularly, it relates to vascular anastomosis devices forjoining the end of a graft vessel, such as a coronary bypass graft, tothe side wall of a target vessel, such as the aorta or a coronaryartery.

BACKGROUND OF THE INVENTION

[0003] Anastomosis is the surgical joining of biological tissues,especially the joining of tubular organs to create an intercommunicationbetween them. Vascular surgery often involves creating an anastomosisbetween blood vessels or between a blood vessel and a vascular graft tocreate or restore a blood flow path to essential tissues. Coronaryartery bypass graft surgery (CABG) is a surgical procedure to restoreblood flow to ischemic heart muscle whose blood supply has beencompromised by occlusion or stenosis of one or more of the coronaryarteries. One method for performing CABG surgery involves harvesting asaphenous vein or other venous or arterial conduit from elsewhere in thebody, or using an artificial conduit, such as one made of Dacron orGoretex tubing, and connecting this conduit as a bypass graft from aviable artery, such as the aorta, to the coronary artery downstream ofthe blockage or narrowing, a graft with both the proximal and distalends of the graft detached is known as a “free graft”. A second methodinvolves rerouting a less essential artery, such as the internal mammaryartery, from its native location so that it may be connected to thecoronary artery downstream of the blockage. The proximal end of thegraft vessel remains attached in its native position. This type of graftis known as a “pedicled graft”. In the first case, the bypass graft mustbe attached to the native arteries by an end-to-side anastomosis at boththe proximal and distal ends of the graft. In the second technique atleast one end-to-side anastomosis must be made at the distal end of theartery used for the bypass. In the description below we will refer tothe anastomoses on a free graft as the proximal anastomosis and thedistal anastomosis. A proximal anastomosis is an anastomosis on the endof the graft vessel connected to a source of blood (e.g., the aorta) anda distal anastomosis is an anastomosis on the end of the graft vesselconnected to the destination of the blood flowing through it (e.g., acoronary artery). The anastomoses will also sometimes be called thefirst anastomosis or second anastomosis, which refers to the order inwhich the anastomoses are performed regardless of whether theanastomosis is on the proximal or distal end of the graft.

[0004] At present, essentially all vascular anastomoses are performed byconventional hand suturing. Suturing the anastomoses is a time-consumingand difficult task, requiring much skill and practice on the part of thesurgeon. It is important that each anastomosis provide a smooth, openflow path for the blood and that the attachment be completely free ofleaks. A completely leak-free seal is not always achieved on the veryfirst try. Consequently, there is a frequent need for resuturing of theanastomosis to close any leaks that are detected.

[0005] The time consuming nature of hand sutured anastomoses is ofspecial concern in CABG surgery for several reasons. Firstly, thepatient is required to be supported on cardiopulmonary bypass (CPB) formost of the surgical procedure, the heart must be isolated from thesystemic circulation (i.e. “cross-clamped”), and the heart must usuallybe stopped, typically by infusion of cold cardioplegia solution, so thatthe anastomosis site on the heart is still and blood-free during thesuturing of the anastomosis. CPB, circulatory isolation and cardiacarrest are inherently very traumatic, and it has been found that thefrequency of certain post-surgical complications varies directly withthe duration for which the heart is under cardioplegic arrest(frequently referred to as the “crossclamp time”). Secondly, because ofthe high cost of cardiac operating room time, any prolongation of thesurgical procedure can significantly increase the cost of the bypassoperation to the hospital and to the patient. Thus, it is desirable toreduce the duration of the crossclamp time and of the entire surgery byexpediting the anastomosis procedure without reducing the quality oreffectiveness of the anastomoses.

[0006] The already high degree of manual skill required for conventionalmanually sutured anastomoses is even more elevated for closed-chest orport-access thoracoscopic bypass surgery, a newly developed surgicalprocedure designed to reduce the morbidity of CABG surgery as comparedto the standard open-chest CABG procedure. This procedure is more fullydescribed in commonly-assigned. U.S. Pat. No. 5,452,733, issued Sep. 26,1995 and U.S. Pat. No. 5,735,290, issued Apr. 7, 1998, the completedisclosures of which are hereby incorporated by reference. In theclosed-chest procedure, surgical access to the heart is made throughnarrow access ports made in the intercostal spaces of the patient'schest, and the procedure is performed under thoracoscopic observation.Because the patient's chest is not opened, the suturing of theanastomoses must be performed at some distance, using elongatedinstruments positioned through the access ports for approximating thetissues and for holding and manipulating the needles and sutures used tomake the anastomoses. This requires even greater manual skill than thealready difficult procedure of suturing anastomoses during open-chestCABG surgery.

[0007] In order to reduce the difficulty of creating the vascularanastomoses during either open or closed-chest CABG surgery, it would bedesirable to provide a rapid means for making a reliable end-to-sideanastomosis between a bypass graft or artery and the aorta or the nativevessels of the heart. A first approach to expediting and improvinganastomosis procedures has been through stapling technology. Staplingtechnology has been successfully employed in many different areas ofsurgery for making tissue attachments faster and more reliably. Thegreatest proaress in stapling technology has been in the area ofgastrointestinal surgery. Various surgical stapling instruments havebeen developed for end-to-end, side-to-side. and end-to-side anastomosesof hollow or tubular organs, such as the bowel. These instruments,unfortunately, are not easily adaptable for use in creating vascularanastomoses.

[0008] This is partially due to the difficulty in miniaturizing theinstruments to make them suitable for smaller organs such as bloodvessels. Possibly even more important is the necessity of providing asmooth, open flow path for the blood. Known gastrointestinal staplinginstruments for end-to-side or end-to-end anastomosis of tubular organsare designed to create an inverted anastomosis, that is, one where thetissue folds inward into the lumen of the organ that is being attached.This is acceptable in gastrointestinal surgery where it is mostimportant to approximate the outer layers of the intestinal tract (theserosa). This is the tissue which grows together to form a strong,permanent connection. However, in vascular surgery this geometry isunacceptable for several reasons. Firstly, the inverted vessel wallswould cause a disruption in the blood flow. This could cause decreasedflow and ischemia downstream of the disruption, or, worse yet, the flowdisruption or eddies created could become a locus for thrombosis whichcould shed emboli or occlude the vessel at the anastomosis site.Secondly, unlike the intestinal tract, the outer surfaces of the bloodvessels (the adventitia) will not grow together when approximated. Thesutures, staples, or other joining device may therefore be neededpermanently to maintain the structural integrity of the vascularanastomosis. Thirdly, to establish a permanent, nonthrombogenic vessel,the innermost layer (the endothelium) should grow together for acontinuous, uninterrupted lining of the entire vessel. Thus, it would bepreferable to have a stapling instrument that would create vascularanastomoses that are everted, that is folded outward, or which createdirect edge-to-edge coaptation without inversion.

[0009] At least one stapling instrument has been applied to performingvascular anastomoses during CABG surgery. This device, first adapted foruse in CABG surgery by Dr. Vasilii I. Kolesov and later refined by Dr,evgenii V. Kolesov (U.S. Pat. No. 4,350,160), was used to create anend-to-end anastomosis between the internal mammary artery (IMA) or avein graft and one of the coronary arteries, primarily the left anteriordescending coronary artery (LAD). Because the device could only performend-to-end anastomoses, the coronary artery first had to be severed anddissected from the surrounding myocardium, and the exposed end evertedfor attachment. This technique limited the indications of the device tocases where the coronary artery was totally occluded, and thereforethere was no loss of blood flow by completely severing the coronaryartery downstream of the blockage to make the anastomosis. Consequently,this device is not applicable where the coronary artery is onlypartially occluded and is not at all applicable to making the proximalside-to-end anastomosis between a bypass graft and the aorta.

[0010] One attempt to provide a vascular stapling device for end-to-sidevascular anastomoses is described in U.S. Pat. No. 5,234,447, granted toKaster et al, for a Side-to-end Vascular Anastomotic Staple Apparatus.Kaster et al, provide a ring-shaped staple with staple legs extendingfrom the proximal and distal ends of the ring to join two blood vesselstogether in an end-to-side anastomosis. However, this device falls shortof fulfilling the desired objectives of the present invention.Specifically, Kaster does not provide a complete system for quickly andautomatically performing an anastomosis. The method of applying theanastomosis staple disclosed by Kaster involves a great deal of manualmanipulation of the staple, using hand operated tools to individuallydeform the distal tines of the staple after the graft has been attachedand before it is inserted into the opening made in the aortic wall. Oneof the more difficult maneuvers in applying the Kaster staple involvescarefully everting the graft vessel over the sharpened ends of thestaple legs, then piercing the everted edge of the vessel with thestaple legs, experimental attempts to apply this technique have provento be very problematic because of difficulty in manipulating the graftvessel and the potential for damage to the graft vessel wall. For speed,reliability and convenience, it is preferable to avoid the need forcomplex maneuvers while performing the anastomosis. Further bendingoperations must then be performed on the staple legs. Once the distaltines of the staple have been deformed, it may be difficult to insertthe staple through the aortotomy opening. Another disadvantage of theKaster device is that the distal tines of the staple pierce the wall ofthe graft vessel at the point where it is everted over the staple.Piercing the wall of the graft vessel potentially invites leaking of theanastomosis and may compromise the structural integrity of the graftvessel wall, serving as a locus for a dissection or even a tear whichcould lead to catastrophic failure. Because the Kaster staple legs onlyapply pressure to the anastomosis at selected points, there is apotential for leaks between the staple legs. The distal tines of thestaple are also exposed to the blood flow path at the anastomotic sitewhere it is most critical to avoid the potential for thrombosis. Thereis also the potential that exposure of the medial layers of the graftvessel where the staple pierces the wall could be a site for the onsetof intimal hyperplasia, which would compromise the long-term patency ofthe graft. Because of these potential drawbacks, it is desirable to makethe attachment to the graft vessel as atraumatic to the vessel wall aspossible and to eliminate as much as possible the exposure of anyforeign materials or any vessel layers other than a smooth uninterruptedintimal layer within the anastomosis site or within the graft vessellumen.

[0011] A second approach to expediting and improving anastomosisprocedures is through the use of anastomotic fittings for joining bloodvessels together. One attempt to provide a vascular anastomotic fittingdevice for end-to-side vascular anastomoses is described in U.S. Pat.No. 4,366,819, granted to Kaster for an Anastomotic Fitting. This deviceis a four-part anastomotic fitting having a tubular member over whichthe graft vessel is everted, a ring flange which engages the aortic wallfrom within the aortic lumen, and a fixation ring and a locking ringwhich engage the exterior of the aortic wall, another similarAnastomotic Fitting is described in U.S. Pat. No. 4,368,736, alsogranted to Kaster. This device is a tubular fitting with a flangeddistal end that fastens to the aortic wall with an attachment ring, anda proximal end with a graft fixation collar for attaching to the graftvessel. These devices have a number of drawbacks that the presentinvention seeks to overcome. Firstly, the anastomotic fittings describedexpose the foreign material of the anastomotic device to the blood flowpath within the arteries. This is undesirable because foreign materialswithin the blood flow path can have a tendency to cause hemolysis,platelet deposition and thrombosis. Immune responses to foreignmaterial, such as rejection of the foreign material or auto-immuneresponses triggered by the presence of foreign material, tend to bestronger when the material is exposed to the bloodstream, as such, it ispreferable that as much as possible of the interior surfaces of ananastomotic fitting that will be exposed to the blood flow path becovered with vascular tissue, either from the target vessel or from thegraft vessel, so that a smooth, continuous, hemocompatible endotheliallayer will be presented to the bloodstream. The anastomotic fittingdescribed by Kaster in the '819 patent also has the potential drawbackthat the spikes that hold the graft vessel onto the anastomotic fittingare very close to the blood flow path, potentially causing trauma to theblood vessel that could lead to leaks in the anastomosis or compromiseof the mechanical integrity of the vessels. Consequently, it isdesirable to provide an anastomosis fitting that is as atraumatic to thegraft vessel as possible. Any sharp features such as attachment spikesshould be placed as far away from the blood flow path and theanastomosis site as possible so that there is no compromise of theanastomosis seal or the structural integrity of the vessels.

[0012] Another device, the 3M-Unilink device for end-to-end anastomosis(U.S. Pat. Nos. 4,624,257; 4,917,090; 4,917,091) is designed for use inmicrosurgery, such as for reattaching vessels severed in accidents. Thisdevice provides an anastomosis clamp that has two eversion rings whichare locked together by a series of impaling spikes on their opposingfaces. However, this device is awkward for use in end-to-sideanastomosis and tends to deform the target vessel; therefore it is notcurrently used in CABG surgery. Due to the delicate process needed toinsert the vessels into the device, it would also be unsuitable forport-access surgery.

[0013] In order to solve these and other problems, it is desirable toprovide an anastomosis device which performs an end-to-side anastomosisbetween blood vessels or other hollow organs and vessels. It is alsodesirable to provide an anastomosis device which minimizes the trauma tothe blood vessels while performing the anastomosis, which minimizes theamount of foreign materials exposed to the blood flow path within theblood vessels and which avoids leakage problems, and which promotesrapid endothelialization and healing. Further, it would be desirable toprovide such a device which could be used in port-access CABG surgery.Whether it is used with open-chest or closed-chest surgical techniques,it is also desirable that the invention provide a complete system forquickly and automatically performing an anastomosis with a minimalamount of manual manipulation.

SUMMARY OF THE INVENTION

[0014] In keeping with the foregoing discussion, the present inventionprovides an anastomosis system for quickly and reliably performing anend-to-side vascular anastomosis. The anastomosis system includes ananastomosis device, an application instrument and methods for their usein performing an end-to-side vascular anastomosis. The system isespecially useful for performing an anastomosis between a vascular graftand the wall of the ascending aorta in CABG surgery, particularly inport-access CABG surgery. One desirable attribute of the anastomosissystem is that the system should be as atraumatic as possible to thegraft vessel in creating the anastomosis, another desirable attribute ofthe anastomosis system is that the anastomosis device should minimizethe amount of foreign material exposed to the blood flow path in thecompleted anastomosis. The anastomosis device of the system has agenerally tubular or ring-shaped body having a proximal end and a distalend. An orifice or internal lumen in the body allows the graft vessel topass through the device from the proximal end to the distal end. Thebody of the device has an attachment means at the distal end forattachment to the graft vessel, generally by everting the graft vesselover the attachment means. Means are provided for attaching the deviceand the graft vessel to the wall of the target vessel. Differentembodiments of the anastomosis device are presented which vary in theform of the means used for attaching to the graft vessel and the targetvessel.

[0015] A first aspect of the present invention takes the form of avascular anastomosis staple device which may be used as part of anoverall anastomosis stapling system and method designed to efficientlyand reliably perform an end-to-side anastomosis between a graft vesseland the wall of a target vessel. The anastomosis staple device forms anatraumatic attachment to the end of the graft vessel so that only asmooth uninterrupted layer of intimal cells is exposed at theanastomosis site or within the graft vessel lumen. The anastomosisstaple device creates a firm, reliable attachment between the graftvessel and the target vessel wall, with a tailored amount of tissuecompression applied at the anastomosis site to form a leak-proof jointbetween the graft vessel and the target vessel wall. The anastomosisstapling system is designed to combine the various functions of graftvessel preparation, target vessel preparation, vessel approximation andanastomosis stapling into an integrated system of instruments so thatthe anastomosis can be performed efficiently with a minimum of manualmanipulation of the vessels or the instruments involved. Differentembodiments of the anastomosis stapling system are provided to meet theneeds of performing either a first anastomosis or a second anastomosisof a bypass procedure. The anastomosis stapling system is configured tobe adaptable for closed-chest or port-access CABG surgery or for moreconventional open-chest CABG surgery.

[0016] In one preferred configuration of the invention, the anastomosisstaple device consists of two parts: an anchor member and a couplingmember. The anchor member forms the attachment with the target vesselwall. The coupling member separately forms the attachment with thebypass graft vessel. The complete anastomosis is created when thecoupling member, with the graft vessel attached, is inserted into theanchor member. In a second preferred configuration of the invention, theanastomosis staple device combines the functions of the anchor memberand the coupling member into a single member. A one-piece anastomosisstaple device attaches to both the target vessel wall and the graftvessel to form a complete end-to-side anastomosis. In all embodiments ofthe anastomosis staple device. certain desirable aspects are maintained,specifically the atraumatic attachment of the device to the graft vesseland the rapid, reliable formation of the anastomosis, as well as theadaptability of the staple device to port-access CABG surgery.

[0017] A second aspect of the present invention takes the form of ananastomotic fitting for attaching the end of a graft vessel to anopening formed in the side wall of a target vessel. The anastomoticfitting has an inner flange which provides an atraumatic attachment forthe everted end of a graft vessel. The inner flange is configured sothat, wherever possible, a smooth, continuous, uninterrupted layer ofintimal tissue lines the graft vessel, the target vessel and theanastomotic site, with as little foreign material as possible exposed tothe blood flow path. The outer flange contacts the exterior surface ofthe target vessel. A locking means, which may be part of the outerflange, locks the outer flange in a fixed position relative to the innerflange. The inner flange, in combination with the outer flange, providesa firm attachment to the target vessel wall. A tailored amount ofcompression applied by the inner and outer flanges grips the targetvessel wall and creates a leak-proof seal between the graft vessel andthe target vessel. Optionally, attachment spikes on the surfaces ofeither the inner or the outer flange provide additional grip on thegraft vessel and/or the target vessel. The attachment spikes areisolated from the blood flow lumens of the graft vessel and the targetvessel so that they do not compromise the anastomotic seal or thestructural integrity of the anastomotic attachment.

[0018] In a first representative embodiment, the anastomotic fitting ismade up of two coacting parts: a) a tubular inner sleeve, which has aninternal lumen of sufficient size to accommodate the external diameterof the graft vessel and an inner flange which is attached at the distalend of the inner sleeve, and b) an outer flange which has a centralorifice that is sized to fit over the exterior of the inner sleeve, anadjustable locking mechanism holds the outer flange on the inner sleeveat a selected position to create a tailored degree of tissue compressionat the anastomotic site.

[0019] The anastomosis procedure is performed by passing the end of thegraft vessel through the inner lumen of the inner sleeve until the endof the vessel extends a short distance from the distal end of thesleeve. The end of the graft vessel is then everted over the innerflange of the fitting to form an atraumatic attachment. A loop of sutureor spikes on the outside of the inner sleeve or flange may be added tohelp retain the graft vessel in its everted position. The inner flangeand the everted end of the graft vessel are then passed through anopening that has previously been made in the wall of the target vesselwith an instrument such as an aortic punch. The opening must stretchslightly to allow the inner flange to pass through. The elastic recoveryof the target vessel wall around the opening helps to create ananastomotic seal by contracting around the inner sleeve and the evertedgraft vessel wall. The outer flange is then slid onto the proximal endof the inner sleeve. If the anastomosis being performed is the firstanastomosis on a free graft, such as a saphenous vein graft, then theouter flange can be slid over the graft vessel from the free end. If theother end of the graft vessel is not free, such as when performing thesecond anastomosis of a free graft or a distal anastomosis on a pedicledgraft like the IMA, then the outer flange should be back loaded onto thegraft vessel or preloaded onto the proximal end of the inner sleevebefore the end of the graft vessel is attached to the inner flange ofthe fitting. The outer flange is slid down the inner sleeve until itcontacts the exterior wall of the target vessel, a tailored amount ofcompression is applied to the anastomosis and the locking mechanism isengaged to complete the anastomosis.

[0020] A second representative embodiment of the anastomotic fitting hasan expanding inner flange which facilitates the atraumatic attachment ofthe graft vessel to the fitting and makes it easier to pass the innerflange and the everted graft vessel through the opening in the targetvessel wall. The graft vessel is passed through an internal lumen of aninner sleeve which has the expandable inner flange attached at itsdistal end. The end of the graft vessel is everted over the unexpandedinner flange. The inner flange and the everted end of the graft vesselare passed through the opening in the target vessel wall. Once the innerflange of the fitting is in the lumen of the target vessel, it isexpanded to a diameter which is significantly larger than the opening inthe target vessel wall. Then an outer flange is applied and locked intoa selected position on the inner sleeve as described above to completethe anastomosis.

[0021] Different mechanisms are disclosed to accomplish the expansion ofthe inner flange. In a first variant of the expanding inner flange, theflange and a portion of the inner sleeve are slotted to create multiplefingers which are initially collapsed inward toward the center of thesleeve. A second inner sleeve is slidably received within the slottedinner sleeve. The graft vessel is inserted through the internal lumen ofboth sleeves and everted over the collapsed fingers of the flange. Thecollapsed flange is inserted through the opening in the target vessel.Then, the second inner sleeve is slid distally within the slotted innersleeve. The second inner sleeve forces the fingers outward, expandingthe flange within the target vessel. The anastomosis is completed byapplying the outer flange to the fitting as described above.

[0022] A second variant of the expanding inner flange has a slottedinner sleeve with multiple fingers that are oriented essentiallylongitudinally to the inner sleeve, each of the fingers has a bend in itto predispose it to bend outward at the middle when under longitudinalcompression. A tubular forming tool slidably received within the slottedsleeve is crenellated with multiple radially extending tabs. Theradially extending tabs engage the distal ends of the fingers of theslotted inner sleeve. The anastomosis is performed by passing the graftvessel through the internal lumen of the fitting and everting it overthe fingers. If desired, a loop of suture can be used to hold theeverted vessel in place. The fingers of the fitting and the everted endof the graft vessel are inserted through an opening in the target vesselwall. When the tubular forming tool is slid proximally with respect tothe slotted inner sleeve, the radially extending tabs bear against thedistal ends of the fingers, compressing them longitudinally. The fingersbow outward, folding at the bend to expand and create an inner flangewhich engages the inner surface of the target vessel wall. In apreferred embodiment of this variation, the slotted inner sleeve has aproximal collar which captures the outer flange of the fitting so thatthe outer flange is applied simultaneously with the expansion of theinner flange. After the inner flange has been expanded, the tubularforming tool can be removed by rotating it with respect to the slottedinner sleeve so that the tabs align with the slots allowing it to bewithdrawn from the fitting. This reduces the mass of foreign materialthat is left as an implant at the anastomotic site.

[0023] A third representative embodiment is a one-piece anastomoticfitting with an inner sleeve that is integrally attached to a fixedinner flange and to a deformable outer flange. The anastomosis isperformed by passing the graft vessel through the internal lumen of theinner sleeve and everting it over the inner flange. The inner flange andthe everted end of the graft vessel are inserted through an opening inthe wall of the target vessel. Then, the outer flange is deformedagainst the exterior surface of the target vessel wall with a tailoreddegree of tissue compression to complete the anastomosis. Two variantsof the deformable outer flange are disclosed. The first variant has anouter flange that is divided into flange segments. The flange segmentsare attached to the inner sleeve by deformable hinges. The secondvariant has an outer flange in the form of a deformable hollow body. Thehollow body is deformed against the exterior surface of the targetvessel to complete the anastomosis.

[0024] The vascular anastomotic fitting is also part of a completeanastomosis system which includes instruments for applying theanastomosis fitting in a rapid, efficient and reliable manner toexpedite the anastomosis process and to reduce the amount of manualmanipulation necessary to perform the anastomosis. The applicationinstrument has an elongated body with means at the distal end forgrasping the anastomosis fitting and inserting the fitting into thechest cavity of a patient through an access port. The instrumentincludes an actuating means for deploying the inner and/or outer flangeof the fitting to create the anastomosis. Variants of the instrument arespecially adapted for each different embodiment and subvariation of theanastomosis fitting.

[0025] A third approach to expediting and improving anastomosisprocedures used by the present invention combines the advantages ofsurgical stapling technology with other advantages of anastomoticfittings. Surgical stapling technology has the potential to improveanastomosis procedures over hand suturing techniques by decreasing thedifficulty and complexity of the manipulations necessary and byincreasing the speed and reliability of creating the anastomosis. TheKaster vascular staple in U.S. Pat. No. 5,234,447 overcomes one of themajor limitations of the previous Kolesov stapling device by allowing astapled end-to-side anastomosis. This device, however, requires manydelicate manual manipulations of the graft vessel and the staple whileperforming the anastomosis. This device therefore does not take fulladvantage of the time saving potential usually associated with staplingtechniques.

[0026] The present invention attempts to marry the advantages ofstapling approaches and anastomotic fitting approaches while carefullyavoiding their potential drawbacks, as such, the present invention takesfull advantage of the speed and reliability of stapling techniques,avoiding inasmuch as possible the need for complex manual manipulations.The invention also profits from the advantages of anastomotic fittingsby providing a ring or flange that exerts even pressure around theanastomotic interface to eliminate potential leaks between the stapledattachments. The ring or flange also serves as a stent or support forthe anastomosis site to prevent acute or long-term closure of theanastomosis. Inasmuch as possible the bulk of the fitting is kept on theexterior of the anastomosis so as to eliminate exposed foreign materialin the bloodstream of the graft vessel or the target vessel. In mostcases, only the narrow staple legs penetrate the anastomosis site, sothat an absolute minimum of foreign material is exposed to the bloodflow path, on the same order as the mass of suture exposed in a standardsutured anastomosis. The attachment technique for the anastomosis deviceeliminates the need to evert the graft vessel over a complex, irregularor sharp object such as the sharpened ends of the staple legs. Instead,a smooth ring or flange surface is provided for everting the graftvessel without damage or undue complication. The staple legs areseparate or recessed within the flange to avoid potential damage to thegraft vessel while attaching it to the device.

[0027] In a third aspect, the present invention takes the form of ananastomosis device which has a ring or flange to which the graft vesselattaches, typically by everting the graft vessel over the distal end ofthe ring. The ring or flange resides on the exterior of the graft vesselso that it does not contact the blood flow path, a plurality ofstaple-like members attach the ring and the everted end of the graftvessel to the wall of the target vessel, which may be the aorta, acoronary artery or other vessel, an opening is created in the targetvessel wall with an aortic punch or similar instrument to allow thetarget vessel lumen to communicate with the graft vessel lumen. Theopening in the target vessel wall can be made before or after the devicehas been attached, depending on the application technique employed. Inmost of the examples disclosed, the staple members pierce the evertedwall of the graft vessel and the wall of the target vessel to hold thetwo vessels together, alternatively, the staple members may enter thelumen of the target vessel through the opening in the wall and thenpierce the wall of the target vessel in the reverse direction. Thisvariation pins together the vascular layers in the target vessel at thecut edge, potentially reducing the incidence of hemodynamicallygenerated dissections in the wall of the target vessel.

[0028] Various configurations of the invention are disclosed which allexhibit the unifying characteristics of a cooperating ring or flange anda plurality of staple members. A first exemplary embodiment includes aring-like fastening flange with deformable staple members for attachingthe flange. A specially adapted staple applying device which operatesthrough the lumen of the graft vessel is used to deform the staples tocomplete the anastomosis. A second embodiment includes a ring-likefastening flange with preformed, spring-like staple members. The elasticmemory of the spring-like staple members holds the anastomosis tightlytogether. A family of embodiments includes a tubular fastening flangewith U-shaped staple members and a locking means for fastening thestaple members to complete the anastomosis. Another family ofembodiments includes one or more ring-shaped fastening flanges withintegrally formed staple members. Another family of embodiments includesa ring-like fastening flange with self-deploying staple members made ofa superelastic metal alloy or a thermally activated shape-memory alloy.A specially adapted staple applying device deploys the superelasticstaple members. The specially adapted staple applying device togetherwith the anastomosis device itself forms a total anastomosis system thatis adaptable or either conventional open-chest CABG surgery orport-access CABG surgery.

[0029] Catheter devices are described which can be used as part of thetotal anastomosis system for isolating a portion of the target artery tofacilitate performing the anastomosis procedure. One catheter device isconfigured to isolate a portion of the ascending aorta wall withoutoccluding blood flow through the lumen of the aorta. A second catheterdevice is configured to be delivered by a transluminal approach forisolating a portion of a coronary artery during the anastomosisprocedure. A third catheter device is configured to be delivered throughthe lumen of the graft vessel for isolating a portion of a coronaryartery during the anastomosis procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030]FIG. 1 is a perspective view of the anchor member and the couplingmember of a two-piece embodiment of the anastomosis staple device of thepresent invention.

[0031]FIG. 2 is a perspective view of a staple applier system forapplying the anastomosis staple device of FIG. 1.

[0032]FIG. 3 is a perspective view of the distal end of the stapleapplier system of FIG. 2 showing the stapling mechanism and the vesselpunch mechanism along with the anchor member of the two-pieceanastomosis staple device of FIG. 1.

[0033]FIG. 4 is a cross sectional view of the distal ends of thestapling mechanism and the vessel punch mechanism of the staple appliersystem of FIG. 2 along with the anchor member of the two-pieceanastomosis staple device of FIG. 1.

[0034] FIGS. 5A-5G are side cross section view showing the sequence ofoperations for creating an end-to-side anastomosis with the two-pieceanastomosis staple device of FIG. 1.

[0035]FIGS. 6A is a perspective view of the graft insertion tool of theanastomosis staple applier system of FIG. 2 prepared for insertion ofthe bypass graft with the coupling member of the two-piece anastomosisstaple device.

[0036] FIGS. 6B-6C are side cross section and perspective views,respectively, of the distal end of the graft insertion tool of FIG. 6A.

[0037] FIGS. 7A-7C are perspective, bottom end, and side cross sectionviews, respectively. showing a variation of the graft insertion toolprepared for creating a second anastomosis of the bypass graft using thetwo-piece anastomosis staple device of FIG. 1.

[0038] FIGS. 8A-8G are side views of various configurations of theattachment legs of the anchor member of FIG. 1 which allow for tailoredamounts of tissue compression at the anastomosis site.

[0039]FIG. 9 is a perspective view of a one-piece embodiment of theanastomosis staple device of the present invention.

[0040]FIG. 10 is a cross sectional view of the one-piece anastomosisstaple device of FIG. 9 being actuated to form an end-to-sideanastomosis.

[0041]FIG. 11 is a cross sectional view of a one-piece anastomosisstaple device with extended first segments on the staple legs.

[0042]FIG. 12 is a cross sectional view of a one-piece anastomosisstaple device with secondary pivot points on the staple legs to createradial tissue compression.

[0043]FIG. 13 is a side cross sectional view of a staple applying toolfor creating an end-to-side anastomosis using the one-piece anastomosisstaple device of FIG. 9.

[0044]FIG. 14 is a cross sectional view of the distal end of the stapleapplying tool of FIG. 13 holding the one-piece anastomosis staple deviceof FIG. 9 with a graft vessel attached thereto.

[0045]FIGS. 15A is a detail drawing of the female bayonet connector onthe distal end of the anastomosis staple applying tool of FIG. 13.

[0046]FIG. 15B is an end view of the male bayonet connector on theproximal end of the one-piece anastomosis staple device of FIG. 9.

[0047]FIG. 16 is a cross sectional schematic of another alternateembodiment of the one-piece anastomosis staple device being actuated toform an end-to-side anastomosis.

[0048]FIG. 17A-17B are a perspective views of a first alternateconstruction of the two-piece anastomosis staple device of FIG. 1.

[0049]FIG. 17C is a cross section view of the anchor member of theanastomosis staple device of FIG. 17A attached to the wall of a targetvessel.

[0050]FIG. 17D is a cross section view of a completed anastomosis usingthe device of FIG. 17A-17B.

[0051] FIGS. 18A-18F show a second alternate construction of thetwo-piece anastomosis staple device of FIG. 1.

[0052]FIG. 19A-19B shows a third alternate construction of the two-pieceanastomosis staple device of FIG. 1.

[0053]FIG. 20 is a side cross section view of a fourth alternateconstruction of the two-piece anastomosis staple device of FIG. 1.

[0054] FIGS. 21A-21C are side partial cross section views of a firstembodiment of an anastomotic fitting according to the invention.

[0055] FIGS. 22A-22C are side cross section views of an anastomosisfitting which is a variation of the embodiment of FIGS. 21A-21C.

[0056]FIG. 22D is a proximal end view of the anastomosis fitting of FIG.22C.

[0057] FIGS. 23A-23D are side cross section views of another variant ofthe embodiment of the anastomosis fitting of FIGS. 21A-21C and FIGS.22A-22C.

[0058] FIGS. 24A-24B are side cross section views of a second embodimentof the anastomotic fitting of the invention having an expanding innerflange.

[0059]FIGS. 24C and 24D are distal end views of the expanding innerflange in the collapsed position and the expanded position,respectively.

[0060] FIGS. 25A-25H show a second variant of the anastomotic fittingwith an expanding inner flange is shown in FIGS. 24A-24D.

[0061] FIGS. 26A-26I show a third embodiment which is a one-pieceanastomotic fitting with a deformable outer flange.

[0062] FIGS. 27A-27D show a second variant of the anastomotic fittingwith a deformable outer flange.

[0063] FIGS. 28A-28I show a third variant of the anastomotic fittingwith a deformable outer flange.

[0064] FIGS. 29A-29C show an embodiment of the anastomotic fittinghaving a secondary flange washer which attaches to the inner flange.

[0065] FIGS. 30A-30K show an embodiment of the anastomotic fittingcombining deformable inner staple members and an outer flange.

[0066] FIGS. 31A-31F show a first embodiment of an anastomotic devicecombining a fastening flange with a plurality of staple members.

[0067] FIGS. 32A-32F show an anastomosis device using preformedspring-like fastening staple members.

[0068] FIGS. 33A-33D show an anastomosis device using S-shaped staplemembers that pierce the interior wall of the target vessel.

[0069] FIGS. 34A-34D show an anastomosis device using S-shaped staplemembers that do not pierce the interior wall of the target vessel.

[0070] FIGS. 35A-35F show an anastomosis device using U-shaped staplemembers with barbed points.

[0071] FIGS. 36A-36C show an anastomosis device using U-shaped staplemembers and a locking collar.

[0072] FIGS. 37A-37C show a second anastomosis device using U-shapedstaple members and a locking collar.

[0073] FIGS. 38A-38C show a one-piece anastomosis device with integralstaple members.

[0074] FIGS. 39A-39C show a second one-piece anastomosis device withintegral staple members.

[0075] FIGS. 40A-40D show a two-piece anastomosis device having twoconcentric ring flanges with integral staple members.

[0076] FIGS. 41A-41E show an anastomosis device having a fasteningflange and a plurality of individual staple members.

[0077] FIGS. 42A-42D illustrate a one-piece embodiment of theanastomosis device with a fastening flange and attached staple members.

[0078] FIGS. 43A-43B show the fastening flange of an anastomosis deviceusing preformed superelastic alloy staple members in a top view and aside view, respectively.

[0079] FIGS. 44A-44B show the superelastic alloy staple members of theanastomosis device in a front view and a side view, respectively.

[0080] FIGS. 45A-45E show the sequence of operations of an applicationinstrument for the anastomosis device of FIGS. 43A-43B and FIGS.44A-44B.

[0081] FIGS. 46A-46D illustrate a second embodiment of the anastomosissystem using an anastomosis device with an inner fastening flange, anouter flange and staple members made of a superelastic alloy.

[0082] FIGS. 47A-47B show an anastomosis staple device combining afastening flange with precurved inner staple members of a highlyresilient material and deformable outer attachment legs in an undeployedstate.

[0083] FIGS. 48A-48B show the anastomosis staple device of FIGS. 47A-47Bin a deployed state.

[0084] FIGS. 49A-49C show the sequence of operations for deploying theanastomosis staple device of FIGS. 47A-47B.

[0085] FIGS. 50A-50B show a staple application instrument for applyingthe anastomosis staple devices of FIGS. 47A-47B.

[0086]FIG. 51 shows a combination strain relief and compliance mismatchtransition sleeve for use with any of the anastomosis devices of thepresent invention.

[0087]FIG. 52 shows a dual-balloon perfusion endoaortic clamp catheterfor isolating a portion of the aortic wall while performing a proximalanastomosis in CABG surgery.

[0088]FIG. 53 shows a dual-balloon coronary isolation and perfusioncatheter for use in performing a distal anastomosis in CABG surgery.

[0089]FIG. 54 shows a T-shaped dual-balloon coronary isolation andperfusion catheter for use in performing a distal anastomosis in CABGsurgery.

[0090]FIGS. 55, 56, 57 show the sequence of operations for creating anend-to-side anastomosis during port-access CABG surgery using theanastomosis stapling system of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0091] The invention will be now be described in detail with referenceto the accompanying drawings. The detailed description describes theinvention in relation to a proximal anastomosis during CABG surgery forjoining the proximal end of the bypass graft to the aortic wall. Thisexample is given by way of illustration only and is in no way meant tobe limiting. Those skilled in the art will recognize that theanastomosis staple device and anastomosis stapling system of the presentinvention are readily adaptable for end-to-side connections of distalanastomoses (i.e, graft to coronary artery anastomoses) during CABGsurgery, as well as for use on other blood vessels and other tubularorgans within the body. For consistency and convenience, throughout thedescription the two ends of the anastomosis staple are referred to asthe proximal and distal ends of the staple, the distal end of the staplebeing the end which is closest to the inner lumen of the target vesseland the proximal end being the free end which is farthest from the innerlumen of the target vessel.

[0092]FIG. 1 is a perspective drawing of a first embodiment of theanastomosis staple device of a first aspect of the present invention.The anastomosis staple device 100 consists of two parts: an anchormember 101, and a coupling member 102. The anchor member 101 forms theattachment to the exterior surface of the wall of a target vessel suchas the aorta. The coupling member 102 forms the attachment to the bypassgraft vessel. When the coupling member is joined to the anchor member,as shown by the dotted lines 103, it forms a complete anastomosis.

[0093] The anchor member 101 has a ring-shaped frame 104 which isconfigured to encircle an opening in the wall of a target vessel, suchas the aorta. The ring-shaped frame 104 has a plurality of attachmentlegs 105, preferably six to twelve, circumferentially spaced around theframe 104 and projecting from the distal end 106 of the ring. The anchormember 101 is preferably made of stainless steel or a titanium alloy forstrength, biocompatibility and absence of MRI interference. Thering-shaped frame 104 and the attachment legs 105 preferably have a wallthickness of approximately 0.2 to 0.6 mm. The width of each of theattachment legs 105 is preferably between 0.5 and 2.0 mm. The attachmentlegs 105 could also be made with a round cross section to eliminatesharp edges which might propagate tears. The precise dimensions of theattachment legs 105 would be a compromise between making the legs rigidenough to pierce the wall of the target vessel without unduedeformation, yet flexible enough to permit the stapling mechanism todeform the attachment legs after they have pierced the target vesselwall to hold the anchor member in place. These dimensions may varydepending on which vessel is chosen as the target vessel for theanastomosis.

[0094] The attachment legs 105 extend first radially outward from thering 104, then there is a transition curve 107, after which the legs 105extend axially away from the ring 104 in the distal direction. Thetransition curve 107 in each attachment leg 105 is shaped so that theanchor member 101 can be placed precisely on the target vessel wall,then affixed firmly in place with minimal displacement of the anchormember 101 or distortion of the target vessel wall. This attachmentprocess will be described more fully in the operational descriptionbelow.

[0095] The points of attachment between the attachment legs 105 and thering-shaped frame 104 in this illustrative embodiment are ail shown asbeing coplanar with one another. In other preferred embodiments, thedistal extremity 106 of the anchor member 111 may be contoured to matchthe curvature of the exterior surface of the target vessel. Thus, thepoints of attachment between the attachment legs 105 and the ring shapedframe 104 will be arranged on a cylindrically curved surface whichintersects the ring 104 of the anchor member 101 rather than a plane.This would be especially important when there is closer parity betweenthe diameter of the graft vessel and the diameter of the target vessel,such as when performing a distal anastomosis between a venous orarterial graft and a coronary artery, because a planar arrangement ofthe attachment legs 105 would not approximate the curvature of thetarget vessel wall as well as for a larger target vessel such as theaorta. In other alternate embodiments, the distal end of the anchormember 106 and the attachment legs 105 may be angled with respect to thering-shaped frame 104 to permit an angled takeoff of the graft vesselfrom the target vessel.

[0096] One preferred configuration for the transition curve 107 in theattachment legs 105 is illustrated in FIG. 1. The first segment 108 ofeach attachment leg extends radially from the ring-shaped frame for ashort distance. The second segment 109 of each leg angles proximallyfrom the first segment at approximately 60° for a short distance. Then,the third segment 110 angles approximately 60° in the distal directionfrom the second segment 109. The fourth segment 111 extends in thedistal direction from the third segment 110 so that the fourth segment111 extends axially away from the ring-shaped frame 104 parallel to thecentral axis of the ring 104. The second 109 and the third 10 segmentsshould be approximately equal in length to one another. The actuallength of the second 109 and third 110 segments will be determined bythe wall thickness of the target vessel. A typical length of 1.5-5 mmwould be used for attachment to the wall of the aorta. The distal ends112 of the attachment legs 105 are sharpened to easily penetrate theaortic wall.

[0097] This illustrates just one preferred transition curve 107 for theattachment legs 105. Alternate transition curves 107 for the attachmentlegs 105 may include arc-shaped segments in place of some of thestraight segments or may include a greater number of straight segmentsto approximate a smoother curve. When choosing alternate curves, it isimportant to preserve the axially extending final segment 111 of theattachment legs in order to penetrate the target vessel wall. Inaddition, it is important to control the amount of distortion of thetarget vessel wall when the anchor member 101 is attached. This is incontrast to many standard wound closure staples which deliberately bunchup the tissue when they are applied to create a closer approximation ofthe tissues being joined. This type of distortion may becounterproductive in attaching a graft vessel to the aortic wall becausethe wall may be too stiff to distort in this manner and the distortionmight cause problems in creating a leak proof seal at the anastomosis.The anvil geometry of the stapling mechanism will also be important indetermining the optimum geometry of the attachment legs.

[0098] The amount of radial compression of the target vessel wall aroundthe anastomosis can be tailored by the choice of the transition curve107 in the attachment legs 105 of the anchor member 101. Radialcompression of the target vessel wall around the anastomosis helps tocreate and maintain an anastomotic seal between the target vessel andthe graft vessel in the completed anastomosis. This is especiallyimportant when blood pressure is restored in the target vessel whichwill tend to stretch the target vessel wall and pull it away from theanastomosis. The radial compression by the attachment legs counteractsthis expansion and maintains the anastomotic seal under pressure. FIGS.8A-8G show various other possible geometries for the attachment legs 105of the anchor member 101 arranged according to the degree of tissuecompression applied to the target vessel wall. FIG. 8A shows a stapleattachment leg 105 where the transition curve 107 consists of a straightsecond segment which extends upward at ninety degrees from the firstradially extending segment. The third segment 110 describes a 90° arcwith a center of rotation at the transition point between the first 108and second 109 segments. The fourth segment 111 extends straight in anaxial direction from the third segment 110. This embodiment of theattachment legs 105 creates very little tissue compression when applied.The amount of tissue compression is indicated by the shaded regionbetween the straight insertion path of the fourth segment 111 and thefinal position of the actuated staple shown in phantom lines 105. FIG.8B shows a transition curve 107 with an elliptically shaped secondsegment 109 which smoothly evolves into an arc-shaped third segment 110with a center of rotation at the transition point between the first 108and second 109 segments. This embodiment creates a slightly greaterdegree of tissue compression. FIG. 8C shows an attachment leg geometrywhich is formed entirely of smooth curves so as to avoid any sharp bendsin the attachment legs 105, but which produces approximately the sametissue compression as the attachment leg of FIG. 8B. FIG. 8D shows atransition curve 107 with a 30° arc-shaped second segment 109 connectingto a 30° arc-shaped third segment 110 with a center of rotation at thetransition point between the first 108 and second 109 segments. FIG. 8Eshows a side view of the embodiment illustrated and described above inFIG. 1. The second segment 109 angles 60° upward from the first segment108, and the third segment 110 angles downward at 60° from the secondsegment 109. This produces a selected degree of tissue compression whenthe attachment legs 105 are actuated.

[0099]FIG. 8F shows an attachment leg geometry which produces slightlygreater tissue compression in the target vessel. The second 109 andthird 110 segments of the transition 107 are smoothly blended togetherin a continuous semicircular arc. FIG. 8G shows an attachment leggeometry which produces even more tissue compression. The second segment109 angles upward at 45° from the first segment 108 and the thirdsegment 110 angles downward from the second 109 at a 90° angle. Manyother attachment leg geometries may be tailored to produce the desireddegree of tissue compression in the target vessel.

[0100] The coupling member 102, as seen in FIG. 1, has a tubular body113 with a passage 114 through it. The distal end of the coupling 102has an atraumatic edge 115 over which the graft vessel will be evertedin forming the anastomosis. The atraumatic edge 115 is important toavoid piercing or damaging the vessel wall in the vicinity of theanastomosis which occurs with some prior art devices. Atraumaticattachment of the graft vessel to the coupling member helps to assure areliable anastomotic seal between the graft vessel and the target vesseland reduces the likelihood of mechanical failure of the graft vesselwall due to punctures or tears in the wall. The exterior of the couplingmember 102 is sized to fit into the interior of the ring-shaped frame104 of the anchor member with enough space between them to accommodateone wall thickness of the bypass graft. The coupling member 102 ispreferably made of stainless steel, a titanium alloy or plastic with awall thickness of approximately 0.1 to 0.6 mm. The exterior of thecoupling member 102 has exterior surface features 116 which serve a dualpurpose. The exterior surface features 116 serve to hold the everted endof the bypass graft onto the coupling member 102, as well as tointerlock the coupling member 102 with the anchor member 101 to completethe anastomosis. Likewise, the interior of the anchor member 101 is madewith interior surface features 117 which interact with the exteriorsurface features 116 to create the interlock. The exterior surfacefeatures 116 of the coupling member 102 could be in the form of bumps,pins, points, barbs, ridges, threads, holes or a combination of thesefeatures. The interior surface features 117 of the anchor member 101would then be in the form of corresponding bumps, pins, points, barbs,ridges, threads or holes to lock the two parts together. It should benoted that, if pins. points, barbs or other piercing members are used asthe interior 117 or exterior 116 surface features of the anastomosisstaple device 100, these potentially traumatic features are located awayfrom the everted edge of the graft vessel and outside of the lumens ofthe graft vessel and target vessel that will serve as the conduit of thebypass so as not to compromise the integrity of the anastomosis.

[0101] In the embodiment illustrated, the coupling member 102 is shownwith bump-shaped exterior surface features 117 that hold the evertedgraft vessel onto the coupling member 102 and interlock with a series ofcircumferential ridges 116 within the anchor member 101. The interiorridges 116 of the anchor member 101 permit a variable degree ofengagement between the coupling member 102 and the anchor member 101 toallow for different wall thicknesses of the target vessel and the graftvessel used in the anastomosis. The axial position of the couplingmember 102 with respect to the anchor member 101 can be varied to createthe desired degree of axial tissue compression to assure an anastomoticseal despite variations in the vessel wall thicknesses.

[0102] The complete anastomosis stapling system includes the anastomosisstaple device 100 and an instrument 118 for applying the anastomosisstaple 100. The instrument 118 for applying the two-part anastomosisstaple 100 consists of three separate, but interacting, mechanisms: astapling mechanism 119, a vessel punch mechanism 120, and a graftinsertion tool 121, 122. Together with the anchor member 101 and thecoupling member 102, they comprise a complete system for performing ananastomosis. In FIG. 2, we can see two of these mechanisms, the staplingmechanism 119 and the vessel punch mechanism 120, assembled togetherwith the anchor member 101 of the anastomosis staple 100, prepared forthe first stage of the anastomosis procedure. The third mechanism, thegraft insertion tool, is shown in two different embodiments 121, 122 inFIGS. 6A-6C and FIGS. 7A-7C, respectively.

[0103] The stapling mechanism 119 and the vessel punch 120 are shownassembled together in a perspective view in FIG. 2. The anchor member101 of the anastomosis staple 100 is held by the staple retainer 123 onthe distal end of the stapling mechanism. This same assembly can be seenin cross section in the operational drawings 5A-5C. The distal end ofthis assembly is shown in greater detail in cross section in FIG. 4. Thestapling mechanism 119 has an inner tube 124 and an outer tube 125 whichare threaded together at their distal ends. The outer tube 125 has ahandle 126 at the proximal end and an annular staple driver 127 at thedistal end of the tube. The inner tube 124 has a staple retainer 123 forholding the anchor member 101 of the anastomosis staple 100 on thedistal end of the tube. The inner tube 124 has an internal lumen 128 ofsufficient size to accommodate the vessel punch mechanism 120 and thegraft insertion tool 121, alternately. The proximal end of the innertube 124 has a pair of opposing slots 129 on the inner surface that actas splines for engagement with a corresponding pair of lugs 130, 134 onthe exterior of the vessel punch mechanism 120 and on the graftinsertion tool 121.

[0104] The vessel punch mechanism 120 is sized to fit through theinternal lumen 128 of the inner tube 124 of the stapling mechanism 119.The vessel punch mechanism 120 has an outer tube 131 and an inner drivemember 132 slidably received within the outer tube. The proximal end ofthe outer tube 131 is attached to a T-shaped handle 133. The outer tube131 has a pair of lugs 130 near the proximal end which extend radiallyfrom the exterior of the tube 131 to engage the opposing slots 129 inthe inner tube 124 of the stapling mechanism 119. The distal end of theouter tube 131 tapers to form a neck 135 which attaches to a cutteranvil 136. The vessel punch cutter 137 is a tubular member which slidestelescopically on the distal end of the outer tube 131 of the vesselpunch 120. The distal edge 138 of the tubular cutter 137 is sharpenedwith an approximately conical bevel 138. The outer tube 131 of thevessel punch mechanism 120 may include a step 139 against which thecutter is located in the retracted position as in FIGS. 5A and 5B. Thetubular cutter 137 is attached to the drive member by a transverse pin140 which extends through a pair of opposing slots 141 in the distal endof the outer tube 131. The proximal end of the drive member 132 isattached to an actuating plunger 142 which extends proximally of theT-shaped handle 133.

[0105] The vessel punch mechanism 120 is actuated by pressing on theactuating plunger 142 to move it with respect to the T-shaped handle133. This linear motion is transferred to the inner drive member 132 andthen, in turn, to the tubular cutter 137 by way of the transverse pin140. The tubular cutter 137 slides forward until the inner lumen of thecutter 137 slides over the anvil 136 in a shearing action. There is avery tight clearance between the inner lumen of the cutter 137 and theouter diameter of the anvil 136. This tight clearance assures a cleanlycut hole through the vessel wall without ragged or torn edges. In FIG.5C, the vessel punch mechanism 120 is shown actuated to cut a holethrough the aortic wall tissue.

[0106]FIG. 3 is a large scale perspective detail drawing of the distalend of the vessel punch mechanism 120 assembled with the staplingmechanism 119. The anchor member 101 of the anastomosis staple 100 isheld by the staple retainer 123 on the distal end of the inner tube 124of the stapling mechanism 119. The ring-shaped frame 104 of the anchormember 101 fits inside of a counterbore 143 on the distal end of theinner tube, as can be seen in FIGS. 4 and 5A-5E. The attachment legs 105of the anchor member 101 are captured and held by the L-shaped grippingfingers 144 which extend from the distal end of the inner tube 124.There are an equal number of gripping fingers 144 on the inner tube 124as there are attachment legs 105 on the anchor member 101, each grippingfinger 144 has an axial slot 145 alongside of it which is at least aswide as the attachment legs 105. The axial slot 145 connects with atransverse slot 146 in the side of each gripping finger 144. The anchormember 101 of the anastomosis staple 100 is loaded onto the stapleretainer 123 by aligning the attachment legs 105 with the ends of theaxial slots 145, pushing the attachment legs 105 to the bottom of theaxial slots 145, then turning the anchor member 101 counterclockwiseuntil the attachment legs 105 enter the transverse slots 146 in the sideof the gripping fingers 144. The anchor member 101 can be secured inthis position by rotating the outer tube 124 of the stapling mechanismto advance it distally until the staple driver 127 contacts theattachment legs 105 with enough force to hold the anchor member 101 inplace without deforming the legs. Alternatively, the inner tube 124 ofthe stapling mechanism 119 could be adapted to grip the ring-shapedelement 104 of the anchor member 101 directly.

[0107] The T-shaped handle 133 of the vessel punch mechanism 120 alsoserves as the handle for the inner tube 124 of the stapling mechanism119 at this stage of the procedure because the lugs 130 on the exteriorof the vessel punch outer tube 131 engage the slots 129 in the interiorof the stapler inner tube 124. Likewise, in the latter stages of theprocedure, the T-shaped handle 133 of the graft insertion tool 121 canalso serve as a handle for the inner tube 124 of the stapling mechanism119 because the lugs 134 of the graft insertion tool 121 engage theinner slots 129 of the stapler inner tube 124 in a similar fashion.Alternatively, the inner tube 124 of the stapling mechanism may besupplied with a separate handle or knob of its own so the inner 124 andouter 125 tubes of the stapling mechanism can be rotated with respect toone another to operate the stapling mechanism when neither the aorticpunch mechanism 120 nor the graft insertion tool 121 is inserted intothe stapling mechanism 119.

[0108] A first embodiment of the graft insertion tool 121 and itsrelationship to the coupling member 102 of the anastomosis staple 100are shown in detail in FIGS. 6A-6C. This embodiment of the graftinsertion tool 121 may be used when the anastomosis staple 100 is usedto form the first anastomosis of the bypass procedure no matter whetherthe first anastomosis is the proximal or the distal anastomosis of thegraft. To prepare the bypass graft for creating the anastomosis, thecoupling member 102 is first loaded onto the distal end of the graftinsertion tool 121. A shoulder 147 on the graft insertion tool 121 holdsthe coupling member 102 in the correct position, and a tightinterference fit or a spring action prevents it from inadvertentlyfalling off. The graft vessel 148 is then loaded into the internal lumen149 of the graft insertion tool 121. This can be done by tying a suturearound the graft vessel on the end opposite to the end that will beanastomosed, passing the suture through the internal lumen 149 of thegraft insertion tool 121, then drawing the graft vessel 148 into thelumen until the end 192 of the graft vessel 148 to be anastomosedextends a short distance from the distal end of the graft insertion tool121. Alternatively, a special tool, such as a narrow pair of endoscopicforceps or a nerve hook, may be used for grasping the graft vessel 148and drawing it through the graft insertion tool 121, at this point, theend 192 of the graft vessel 148 to be anastomosed is everted over theend of the graft insertion tool 121 and the coupling member 102, asshown in FIGS. 6A-6C. The external surface features 116 of the couplingmember 102 serve to hold the graft vessel onto the exterior of thecoupling member 102 in the everted position. The external surfacefeatures 116 of the coupling member may at least partially penetrate thewall of the graft vessel 148 to provide greater holding force.

[0109] With the anchor member 101 loaded onto the stapling mechanism 119and the graft vessel 148 prepared by everting and attaching it to thecoupling member 102 as described above, the device is ready to performthe end-to-side anastomosis, as illustrated in FIGS. 5A-5G. Referringnow to FIG. 5A, the stapling mechanism 119 and the vessel punchmechanism 120 are shown assembled together, a slit 150 is made in thetarget vessel wall 150 with a scalpel or other sharp instrument, and theanvil 136 of the vessel punch 120 is inserted through the slit 151 intothe lumen of the target vessel 150. The anvil 136 serves to center thestapling mechanism 119 and the anchor member 101 around the chosenattachment point on the target vessel 150 where the slit 151 is made.The stapling mechanism 119 is advanced over the vessel punch mechanism120 toward the wall of the target vessel 150, as shown in FIG. 5B. Aslight tension is maintained on the T-handle 133 of the vessel punchmechanism 120 so that the anvil 136 supports the wall of the targetvessel 150 as the attachment legs 105 of the anchor member 101 contactand penetrate the target vessel wall 150. The fourth segments 111 of theattachment legs 105 penetrate the target vessel wall 150 in a linearpath. Once the fourth segments 111 of the attachment legs 105 havetraversed the target vessel wall 150, the attachment legs 105 areactuated, as shown in FIG. 5C. The outer tube 125 of the staplingmechanism 119 is advanced over the inner tube 124 by rotating the handle126 of the outer tube 125 with respect to the T-handle 133 of the vesselpunch mechanism 120. This advances the staple driver 127 against theattachment legs 105, deforming them into the position shown in FIG. 5C.After the attachment legs 105 have been actuated, the tubular cutter 137of the vessel punch mechanism 120 is advanced with respect to the anvil136, as shown in FIG. 5D, by pressing on the actuating plunger 142 atthe proximal end of the drive member 132. The punch mechanism 120creates an opening 152 through the target vessel wall 150. The vesselpunch mechanism 120 with the tissue 153 that was excised by the punchcan now be withdrawn from the inner lumen 128 of the stapling mechanism119, as shown in FIG. 5E, leaving the anchor member 101 attached to thetarget vessel wall 150 in alignment with the opening 152 punchedtherein.

[0110] The graft vessel insertion tool 121 with the prepared graftvessel 148 and coupling member 102 in place is inserted into the innerlumen 128 of the stapling mechanism 119 as shown in FIG. SF. Thecoupling member 102 is pressed into the ring-shaped frame 104 of theanchor member 101 and the exterior features 116 on the coupling member102 engage the interior features 117 of the ring-shaped frame 104 tohold the coupling member 102 and the anchor member 101 together. Thestaple retainer 123 of the stapling mechanism 119 still has a firm graspon the anchor member 101 to provide support as the coupling member 102is pressed into the ring-shaped frame 101. The coupling member 102should be pressed into the ring-shaped frame 104 until the everted endof the graft vessel 148 bears against the exterior surface of the targetvessel wall 150, creating a fluid tight seal at the anastomosis site.Alternatively, the coupling member 102, with the everted end of thegraft vessel 148 attached, can be made to extend into the opening 152 inthe target vessel wall 150 with the target vessel wall 150 creating aradial compression around the graft vessel 148 and the coupling member102. The stapling mechanism 119 can now be disengaged from the from theanchor member 101 by turning the handle 126 of the outer tube 125 withrespect to the T-handle 133 of the graft insertion tool 121 until thestaple driver is withdrawn from the attachment legs 105. Then the innertube 124 of the stapling device can be turned counterclockwise byturning the T-shaped handle 133 of the graft insertion tool 121 todisengage the gripping fingers 144 of the staple retainer 123 from theattachment legs 105 of the anchor member 101. A complete end-to-sideanastomosis, as shown in FIG. 5G, is left at the anastomosis site.

[0111] It should be noted that the order of the steps of the anastomosisprocedure 127 could be altered. For instance, the opening could be firstpunched in the target vessel with an aortic punch or similar instrument,and then the anchor member of the staple could be attached. In thisinstance, the graft vessel could be attached to the anchor member eitherbefore or after the anchor member is attached to the target vessel.Other variations in the order of the steps are also possible.

[0112]FIG. 7A shows a perspective drawing of a second embodiment of thegraft insertion tool 122 for use in performing the second anastomosis ona graft vessel, one end of which has already been anastomosed, or forother situations when both ends of the graft vessel are not available,such as when making the distal anastomosis on an internal mammary arterybypass graft. This embodiment of the graft insertion tool 122 is madewith a two-part, hinged holder 154 for the coupling member of theanastomosis staple device so that the holder 154 can be removed fromaround the graft vessel 148 after both ends of the graft have beenanastomosed. The holder 154 is attached to the distal end of a tubularmember 155 which is attached on its proximal end to a handle grip 156. Ashaft 157 is slidably received within the tubular member 156. The distalend of the shaft 157 is attached to a U-shaped yoke 158 which isconfigured to grip a flange 159 or a pair of lugs on the proximal end ofthe anchor member 101. The handle grip 156 has a coacting trigger member160 which is attached to the proximal end of the shaft 157 through aslot 161 in the side of the tubular member 155. The holder 154 is springbiased toward the open position 154′. The force of the spring actionhelps the holder 154 to grip the coupling member 102 so that it does notslip off of the holder 154 prematurely. A distal end view of the holder154 is shown in FIG. 7B, with the holder 154 shown in both the closedposition and the open position (phantom lines 154′).

[0113] To prepare the graft vessel 148 for the anastomosis, the couplingmember 102 is first placed onto the holder 154 and the end of the graftvessel 148 to be anastomosed is passed through the lumen 162 of theholder 154 and the coupling member 102 from the proximal to the distalend. The end of the graft vessel 148 is then everted back over thecoupling member 102, as shown in FIG. 7C. The external surface features116 on the coupling member 102 will hold the everted vessel in place onthe coupling member. In FIG. 7C, the anchor member 101 of theanastomosis staple device 100 has been fastened to the target vessel150, as described above in relation to FIGS. 5A-5E, and the staplingmechanism 119 has been removed by turning the handle 126 of the staplingmechanism 119 counterclockwise relative to the handle 126 on the vesselpunch mechanism 120 until the anchor member 101 is released. The graftinsertion tool 122 with the prepared graft vessel 148 is now positionedat the anastomosis site and the U-shaped yoke 158 is used to grip theanchor member 101, retained by the flange 159 on its proximal end. Withthe graft vessel 148 and the coupling member 102 aligned with the anchormember 101 as shown, the handle grip 156 and the trigger 160 aresqueezed together to press the coupling member 102 into the anchormember 101 until the everted end of the graft vessel 148 is pressedagainst the outer surface of the target vessel 150 creating a leak-proofanastomosis. The holder 154 is then retracted from the coupling member102 by moving the trigger 160 away from the handle grip 154. The hingedholder 154 opens when it is withdrawn from the coupling member 102,releasing the graft vessel 148 from the lumen 162 of the holder 154. TheU-shaped yoke 158 can now be slid sideways off of the anchor member andthe anastomosis is complete.

[0114] A one-piece version of the anastomosis staple device of thepresent invention along with a specially adapted staple applying toolwill now be described in detail. In the one-piece embodiments whichfollow, a tubular member, analogous to the coupling member of thepreviously described embodiment, is permanently attached to a circularstaple member, which is analogous to the anchor member 101 of thepreviously described embodiment.

[0115]FIG. 9 shows a perspective view of a first embodiment of theone-piece anastomosis staple device 163 of the present invention. Thissame embodiment is shown in cross section in FIGS. 11 and 13. Theanastomosis staple 163 has a tubular body member 164 which has an innerlumen 165 sized to accommodate the exterior diameter of the graft vessel148. Means for attaching the graft vessel 148 are provided at the distalend of the tubular body member 164 or on the outside of the tubularmember 164. In the preferred embodiment, the means for attaching thegraft vessel 148 to the anastomosis staple 163 is a tubular distalextension 166 of the tubular body over which the graft vessel 148 iseverted. The tubular extension 166 may include a flange 167 to securethe attachment of the everted graft vessel 148 to the tubular extension166. This flange 167 may also engage the inner surface of the targetvessel 150 to help retain the graft 148 in place.

[0116] The anastomosis staple device 163 has a multiplicity of staplelegs 168 extending from the tubular body member 164 proximal to thetubular distal extension 166. Optionally, the tubular body member 164may extend proximally 169 from the staple legs 168 as shown, or thetubular body member can be truncated at or near the level of the staplelegs to decrease the overall profile of the staple. The optionalproximal extension 169 of the tubular body member 164 may include lugsor tabs 170 or a flange or other features that can be used for grippingthe staple 163 by a staple applying tool.

[0117] The anastomosis staple 163 typically has five to twelve staplelegs 168 for attaching to the target vessel wall 150. The presentlypreferred embodiment of the staple 163 has six staple legs 168 asillustrated in FIG. 9. The staple legs 168 are distributedcircumferentially around the exterior of the tubular body member 164.The staple legs 168 can be formed integrally with the tubular bodymember 164, or they can be manufactured separately and attached to thetubular body member 164. Optionally, the exterior of the tubular bodymember 164 may include a circumferential ledge 171 to which the staplelegs 168 are attached. In the pre-actuated position, the legs 168 angleproximally from where they attach to the tubular body member 164 so thatthe sharpened tips 172 of the staple legs are proximal to the point ofattachment with the body. The staple legs 168 have a first segment 173which extends approximately straight from the tubular body member; thenthere is a transitional segment 174 and a curved end segment 175. Thecurved end segment 175 of each staple leg has a sharpened tip 172 foreasily piercing the wall of the target vessel 150. The curve of the endsegment 175 is a circular arc whose center of rotation coincidesapproximately with the point of attachment 176 between the staple legand the tubular body member. The point of attachment 176 serves as apivot point for the staple leg 168 when it is actuated, so that the endsegment 175 of the staple legs 168 describes an arc-shaped path throughthe tissue of the target vessel wall that follows the curvature of thearc-shaped end segment 175.

[0118] The transition segment 174 of the staple legs 168 can take on oneof several forms depending on the effect desired in the actuated staple.If the transition segment 174 is largely a right-angle bend, so thatonly the end segment 175 penetrates the tissue, then the staple legs 168will cause very little radial compression of the target vessel walltissue 150 as the staple 163 is actuated. If, on the other hand, thetransition segment 174 has a curve of smaller radius than that of thecurved end segment 175, the tissue will be compressed and pulled towardthe tubular body member 164 as the transition segment 174 enters andtravels through the target vessel wall 150, as illustrated in FIG. 10.The degree of radial tissue compression can be regulated to theappropriate amount by proper design of the curve in the transitionsegment 174 of the staple legs 168. In addition, the shape of the firstsegment 173 may help to define the surface shape of the target vessel150 after the staple 163 is applied. It may be desirable to keep it asflat as possible, or it may be desirable to “tent up” the target vesselsomewhat in the area of the anastomosis. Optionally, the first segmentmay be given greater effect on the target vessel surface shape byextending the first segment 173 beyond the transition point with thesecond segment 174, as shown in FIG. 11. The straight extension 177 ofthe first segment 173 beyond the attachment point of the transitioncurve 174 will tend to flatten out the tissue of the target vessel wall150 at the anastomosis site so that undue deformation of the vessel walldoes not compromise the integrity of the anastomosis.

[0119]FIG. 12 shows another means for accomplishing the tissuecompression performed by the transition segment 174 of the staple legs168 in the embodiment of FIGS. 9 and 10. In this embodiment, thetransition segment 174 of the staple legs 168 is essentially a rightangle bend with very little radiusing, so the staple legs 168 cause verylittle tissue compression as they pierce the target vessel wall 150 andtravel through the tissue. However, before the staple legs 168 havereached the end of their travel, the first segment 173 comes intocontact with a circumferential ledge 178 that extends outward from thetubular body member 164 just below the attachment point 176 of thestaple legs 168. When the staple leas 168 contact the edge 178, thefirst segments 173 of the legs bend where they contact the outer edge ofthe ledge 178. This moves the center of rotation outward and shortensthe radius of rotation of the curved end segment 175 so that the staplelegs will pull the tissue of the target vessel wall 150 toward thetubular body member 164, compressing the tissue.

[0120] The staple legs 168 are preferably dimensioned so that the staplelegs travel all the way through the target vessel wall 150 when thestaple is actuated. In the embodiment of FIG. 10, after actuation, theends 172 of the staple legs 168 rest just distal to the flange 167 onthe distal end 166 of the tubular body member 164. In the embodiment ofFIG. 12, the staple legs 168 are configured to pierce the wall of thegraft vessel 148 just proximal to the flange 167 on the distal end 166of the tubular body member 164, adding to the security of theattachment. In both embodiments the flange 167 supports the tissue ofthe target vessel wall 150 as the ends 172 of the staple legs 168emerge, helping to insure that the staple legs 168 will pierce cleanlythrough the target vessel wall 150 without separating the lamina, whichcould lead to dissection. In both cases, the staple legs 168 areconfigured so that the curved end segments 175 of the staple legs 168are driven all the way through the target vessel wall 150 before thereis significant compression of the tissues. The tubular body member 164isolates the cut edge at the opening 152 in the target vessel wall 150from the blood flow path so that blood pressure will not causedelamination of the target vessel wall 150. The staple legs 168, thetubular body member 164 and the flange 167 form a closed loop, similarto a sutured attachment. These factors also help to minimize the dangerof dissection of the target vessel wall 150.

[0121]FIG. 13 shows one preferred embodiment of the one-pieceanastomosis staple 163 mounted on the distal end of a specially adaptedstaple applying tool 179. The staple applying tool 179 has an outer tube180 and an inner tube 181 slidably received within the outer tube 180.The inner tube 181 has an inner lumen 182 of sufficient diameter toaccommodate the outer diameter of the graft vessel 148 that will be usedfor the anastomosis.

[0122] The staple applying tool 179 has a main body 183 which is shapedin the form of a pistol grip. The proximal end of the inner tube 181 isanchored with respect to the main body 183 by a flange 184 or otherattachment on the proximal end. The outer tube 180 is slidable withrespect to the inner tube 181 by actuating the lever 185 of the stapleapplying tool 179 which engages a pair of pins 186 attached to theexterior of the outer tube. Pulling the lever 185 advances the outertube 180 distally over the inner tube 181, a return spring 187 attachedto the lever 185 returns the lever 185 and the outer tube 180 to theirunactuated positions.

[0123] A close-up view of the anastomosis staple 163 and the distal endof the staple applying tool 178 is shown in FIG. 14. The anastomosisstaple 163 in this embodiment has a tubular body 164 which ispermanently attached to a plurality of circumferentially distributedattachment legs 168. The tubular body 164 has a distal tubular extension166 with a flange 167 for eversion and attachment of the craft vessel148. There is also a proximal tubular tension 169 which has a pair oftabs 170 for grasping the staple with a staple retainer 188 on thedistal end of the inner tube 181 of the staple applying tool 179, an endview of the tabs 170 is shown in FIG. 15A. The staple retainer 188 atthe distal end of the inner tube 181 shown in detail in FIG. 15B, has apair of longitudinal slots 189 corresponding to the two tabs 170 of theanastomosis staple. Connected to the longitudinal slots 189 is acircumferential groove 190 within the inner tube 188. The staple 163 isattached to the staple retainer 188 by aligning the tabs 170 with thelongitudinal slots 189 and sliding the tabs into the slots 189. When thetabs 170 reach the bottom of the longitudinal slots 189, the staple 163is rotated with respect to the inner tube 181 so that the tabs 170 enterthe circumferential groove 190. A ridge 191 on the distal side of thegroove 190 holds the tabs 170 within groove 190 to retain the staple 163on the end of the inner tube 181.

[0124] It should be noted that a number of methods of attaching thetubular member 164 to the stapling mechanism 179 are possible besidesthe bayonet attachment illustrated. The end of the stapling mechanism179 may be configured to grasp the tubular member 164 on the innerdiameter or the outer diameter distal to the point of attachment 176 ofthe staple legs 168, allowing the proximal tubular extension 169 of theanastomosis staple 163 to be eliminated. This modification would allow alower profile anastomosis attachment to be created.

[0125] To prepare the graft vessel 148 for anastomosis, an anastomosisstaple 163 is attached to the distal end of the staple applying tool 179as just described, then, using a suture or an elongated grasping tool,the graft vessel 148 is drawn into the inner lumen 182 of the tool untilthe end 192 of the graft vessel 148 to be anastomosed extends a shortdistance from the distal end of the tool. At this point, the end 192 ofthe graft vessel 148 to be anastomosed is everted over the distaltubular extension 166 and the flange 167 as shown in FIG. 14. A suturecan be tied around the everted end 192 of the graft vessel 148 proximalto the flange 167 to retain the graft vessel 148 on the staple 163, ifdesired.

[0126] Thus prepared, the staple 163 is advanced toward an opening 152that has been previously made in the target vessel wall 150 with anaortic punch or other appropriate tool. Preferably, the opening 152 ismade with a diameter approximately equal to the outer diameter of thedistal tubular extension 166 of the staple 163 just proximal to theflange 167. The flange 167 with the everted end 192 of the graft vessel148 is passed through the opening 152 in the target vessel 150, as shownin FIG. 10. The target vessel wall 150 may need to be stretched slightlyto allow the flange 167 to pass through the opening 152. The elasticrecovery of the target vessel wail 150 creates a compressive force wherethe target vessel wall 150 surrounds the distal tubular extension 166with the everted end 192 of the graft vessel 148 which contributes tothe fluid-tight seal of the anastomosis.

[0127] Once the flange 167 has been passed through the opening 152 inthe wall of the target vessel 150, the anastomosis staple 163 is pulledback slightly so that the flange 167, covered by the everted graftvessel wall 192, is against the inner surface of the target vessel wall150. Then, the staple 167 is actuated by pulling on the lever 185, whichmoves the outer tube 180 distally until the staple driver 193 at thedistal end of the outer tube 180 bears on the attachment legs 168. Asthe staple driver 193 advances, the attachment legs 168 bend at thefulcrum 176 where they attach to the tubular member 164. The arc-shapedthird segments 175 of the attachment legs 168 penetrate and traverse thewail of the target vessel 150. Once the third segments 175 of theattachment legs 168 have traversed the wall, the staple 163 begins tocompress the tissue of the target vessel wall 150 radially against thedistal tubular extension 166 of the anastomosis staple 163 by any of themechanisms previously discussed. After the attachment legs 168 of theanastomosis staple 163 have been fully actuated, the lever 185 isreleased and the staple applying tool 179 is rotated to disengage thestaple retainer 188 from the tabs 170 on the proximal tubular extension169 of the staple 163. The staple applying tool 179 is withdrawn and theanastomosis is complete.

[0128]FIG. 16 shows another potential configuration for the staple legs194 of the one-piece anastomosis staple 195. In this embodiment, thestaple legs 194 have a compound curved transition segment 197 whichprovides two different axes of rotation for the staple legs 194 as theyare actuated. The staple legs 194 attach to the proximal end of thetubular body member 198. A first segment 199 of the staple leg 194extends approximately radially from the point of attachment 206. Thereis a U-shaped bend 200 at the end of the first segment 199 that connectsit to a second segment 201 which lies roughly parallel to the firstsegment 199. A third segment 202 attaches the second segment 201 to thefourth, and most distal, segment 203 of the staple leg. The fourthsegment 203 has an arc-shaped curve whose center of rotation isapproximately at the center of the U-shaped curve 200 between the first199 and second 201 segments. The distal tip 204 of the fourth segment203 is sharpened so that it easily penetrates the target vessel wall150.

[0129] In the operation of this embodiment of the anastomosis staple,the staple legs 194 are initially in the position shown by solid lines194 in FIG. 16. In this position the staple legs 194 are held well abovethe flange 205 on the distal end of the tubular body member, making iteasier to insert the flange 205, with the everted graft vessel 192attached, into the opening in the target vessel 150 and to seat theflange 205 against the inner surface of the target vessel 150. When thestaple driver is advanced, the staple legs 194 initially rotate aboutattachment point 206 between the first segment and the tubular bodymember. After the staple leg 194 has rotated approximately 90 degrees,to the position shown by phantom lines 194′, the first segment 199 comesinto contact with the exterior of the tubular body member 198 and itstops rotating. Advancing the staple driver further causes the second201, third 202 and fourth 203 segments of the staple leg 194 to rotatearound the U-shaped curve 200 connecting the first 199 and second 201segments. The U-shaped curve 200 opens up to about 90 degrees as thecurved fourth segment 203 of the staple leg 194″ penetrates the targetvessel wall 150, attaching the graft vessel 148 to the target vessel 150to complete the anastomosis.

[0130] Another embodiment of the two-piece anastomosis staple is shownin FIGS. 17A-17D. This embodiment differs somewhat in its constructionfrom the embodiment of FIG. I although the operational principles arebasically the same. The anastomosis staple 207 again includes an anchormember 208 and a coupling member 209 which interconnect. The anchormember ′208 is made with a ring-shaped frame 210 which is pierced by twoparallel rows of slots 211, 212. The metal 213 between the slots 211,212 is deformed outward slightly to allow insertion of wire attachmentlegs 214. After the attachment legs 214 are inserted, the metal 213 ispressed inward to firmly attach the wire attachment legs 214 to theframe 210. Either before or after attachment to the ring-shaped frame210, the wire attachment legs 214 can be formed with a desired curve,such as one of the curves described in FIGS. 8A-8G. The distal tips 215of the wire attachment legs are sharpened so that they easily penetratethe target vessel wall 150. The use of round wire attachment legs 214with conically sharpened points 215, as opposed to the flat attachmentlegs 105 with chisel-shaped points 212 of FIG. 1, has shown someadvantage in preliminary testing, in that the round wire legs 214 causeless trauma to the tissue of the target vessel wall 150 as theypenetrate it. This may be due to the tendency of the conically sharpenedtips 215 of the attachment legs 214 to dilate the tissue as they passthrough the target vessel wall 150 more than to cut it. The tissue ofthe target vessel wall 150 is thus left more intact and may be lessprone to dissections or other structural failure.

[0131] A plurality of retaining clips 216 are integrally formed on theproximal edge of the ring-shaped frame 210. The retaining clips 216perform the function of coupling the anchor member to the couplingmember, similar to the interior surface features 117 of the anchormember 101 of FIG. 1. The coupling member 209, shown in FIG. 17B, has atubular body 217 with a plurality of graft holding points 218 extendingfrom its distal edge. If desired, the graft holding points 218 could berelocated, replaced with other gripping features, or eliminated entirelyto avoid piercing the graft vessel 148 at the point of eversion. Thegraft holding points 218 perform one of the functions of the exteriorsurface features 116 of the coupling device 102 shown in FIG. 1 in thatthey attach the graft vessel 148 to the coupling member 209.

[0132] This embodiment of the two-piece anastomosis staple 207 can beapplied with a slightly modified version of the anastomosis staplingtool 118 of FIGS. 2, 6 and 7, following the sequence of steps of FIGS.5A-5G. The inner tube 124 of the stapling mechanism 119 grasps theanchor member 208 by either the ring-shaped frame 210 or the firstsegment of the attachment legs with the L-shaped legs of the stapleretainer. After a small incision 151 has been made in the target vesselwall 150 at the desired anastomosis site, the stapling mechanism 119,with the vessel punch mechanism 120 inserted into the inner lumen 128,is positioned at the anastomosis site. The anvil 136 of the vessel punch120 is inserted through the incision 151 and drawn back slightly tosupport the target vessel wall 150 so that the wire attachment legs 214can be driven into the wall 150. The wire attachment legs 214 are thendeformed by the stapling mechanism 119 to attach the anchor member 208to the target vessel wall 150. The vessel punch 120 is then actuated toform a hole 152 through the target vessel wall 150 centered within thering-shaped frame 210, as described in relation to FIG. 5D. The anchormember 208 is now attached to the target vessel wall 150 with the ringshaped frame 210 centered around the opening in the vessel wall 152, asshown in FIG. 17B. In this illustrative embodiment, the wire attachmentlegs 214 are configured so as to only partially penetrate the targetvessel wall 150 so that they are embedded within the target vessel wall150 in their final, deployed configuration. This variation of the methodmay be preferred for attachment to some types of body tissues as thetarget vessel 150. The wire attachment legs 214 may also be piercedthrough the entire target vessel wall 150 before they are deformed sothat they reside against the interior of the target vessel wall 150, asshown in FIG. 5C.

[0133] Once the anchor member 208 is attached to the target vessel 150,the vessel punch mechanism 120 is withdrawn and the graft insertion tool121 with the graft vessel 192 everted over the distal end of thecoupling member 209 is inserted into the inner lumen 128 of the staplingmechanism 119. The graft insertion tool 121 is used to press thecoupling member 209 into the ring-shaped frame 210 of the anchor member208 until the everted end 192 of the graft vessel 148 is firmly sealedagainst the outer surface of the target vessel wall 150 and theretaining clips 216 have seated over the proximal end of the couplingmember 209. The coupling member 209 is held in the ring-shaped frame 210by the retaining clips 216. The graft holding points 218 may be made sothat they penetrate through the graft vessel wall 192 and into thetarget vessel wall 150, as shown in FIG. 17C, to increase the securityof the anastomosis attachment. It should be noted that other sequencesof operations are also possible for this embodiment, such as punchingthe opening in the target vessel wall prior to attachment of the anchormember.

[0134] Another embodiment of the two-piece anastomosis staple device 219is shown in FIGS. 18A-18F. This embodiment of the device lends itself todifferent manufacturing methods than the previously describedembodiments. The anchor member 2′0 shown in perspective in FIG. 18A canbe formed from a single piece of sheet metal by a combination ofpunching and drawing steps. The anchor member 220 has a plate 221 whichis curved to fit the contours of the exterior surface of the targetvessel wall 150, as seen in the end view FIG. 18B. For performing anaortic anastomosis, the radius of curvature of the plate 221 wouldtypically be between 10 and 20 mm in an adult human. The plate 221 wouldbe approximately 10 to 20 mm in width and 10 to 25 mm in length. Theplate 221 is punched so as to form integral attachment legs 222. Thisillustrative embodiment is shown with four integrally formed attachmentlegs 222, as best seen in top view FIG. 18C. A tubular proximalextension 223 is formed on the curved plate 221 by drawing the sheetmetal plate 221 to form a cylindrical extension 223, then piercing ordrilling it to open the proximal end of the cylinder. A final forming orstamping operation forms a radiused flange 224 at the proximal end ofthe tubular extension 223 that serves as a strain relief to preventsharp bends or kinking of the graft vessel 148 close to the anastomosissite.

[0135] This embodiment of the anchor member can be attached to thetarget vessel wall by a sequence of operations similar to that describedin relation to FIGS. 5A-5G. Alternatively, the sequence of operationscan be re-ordered so that the target vessel is punched before placementof the anchor member similar to that described for the one-pieceembodiment of FIG. 9. Thus, either of the anastomosis staplingmechanisms 118, 179 previously described could easily be adapted to holdthe anchor member 208 of FIG. 18 and to drive the attachment legs 222into the target vessel wall 150.

[0136] The coupling member 225 in this embodiment is a toroidal ring 225made of a resilient biocompatible material such as plastic, rubber or aspringy metal having an outside diameter slightly smaller than theinside diameter of the cylindrical extension 223. The coupling member225 is shown in Fir. 18D. The graft vessel 148 is prepared foranastomosis by passing the end of the vessel through the central openingof the toroidal ring 225 and everting it back 192 over the ring, asshown in the FIG. 18E. The ring 225, with the graft vessel 192 evertedover it, is then collapsed or folded enough so that it can be insertedinto the proximal tubular extension 223 of the anchor member 220. Oncethrough the cylindrical extension 223, the toroidal ring 225 recoils toits expanded size, sealing the graft vessel wall 192 against the wall ofthe target vessel 150 and preventing the end of the graft vessel 192from pulling out of the tubular extension 223. Alternatively, acylindrical ring-shaped coupling member with locking features, similarto those shown in FIGS. 1 and 17B, can be used in conjunction with theanchor member of FIG. 18A.

[0137]FIGS. 19A and 19B show an alternate construction 226 of thetwo-piece anastomosis staple 219 device of FIGS. 18A-18E. In thisvariation of the device, the anchor member 227 may be made from a flatpiece of sheet metal that is punched to form a flange 238 with a centralaperture 228 and integrally formed attachment legs 229. The anchormember 227 is attached to the target vessel 150 with the centralaperture aligned 228 with a preformed hole 152 in the wall of the targetvessel 150. Alternatively, the anchor member 227 can be placed beforethe hole 152 is punched. The attachment legs 229 are shaped withstraight distal segments, as shown by the phantom lines 231′, thatpenetrate the target vessel wall 150 in a linear fashion. A staplingdevice with a staple deforming anvil is passed through the hole 152 inthe target vessel wall 150 to deform the attachment legs 229 so thatthey grip the target vessel wall 150, as shown by the solid lines 231.The attachment legs 229 can be deformed one at a time or some or all ofthe attachment legs 229 can be deformed at once depending on the designof the stapling device. Alternatively, the attachment legs 229 can beprecurved and driven into the target vessel wall 150 from the outside.

[0138] The central aperture 228 in the flange 230 of the anchor member227 has attachment features that interlock with matching attachmentfeatures on a first tubular coupling member 232. As an illustration ofone possible configuration, the first coupling member is shown with twopairs of tabs 233, 234 extending radially from the distal edge of thefirst tubular coupling member 232. One pair of tabs 234 is slightly moredistal than the other pair 233. The central aperture 228 of the anchormember 227 has a matching pair of slots 235 extending from the aperture228. The first coupling member 232 is joined to the anchor member 227 byaligning the more distal pair of tabs 234 with the slots 235, pushingthe tabs 234 through the slots 235, then turning the coupling member 232until the tabs 234 are locked onto the edges of the aperture 228. Thefirst tubular coupling member 232 may be made with integrally formedgraft holding points 236 which are cut and bent inward from the wall ofthe first tubular coupling member 232 to hold the everted graft inplace. The graft may be everted over a second tubular coupling member196, which is inserted into the first tubular coupling member 232 and isattachable to the first tubular coupling member at the proximal ends ofthe tubular coupling members, as shown in FIG. 19B.

[0139]FIG. 20 shows a fourth alternate construction 237 of the two-pieceembodiment of the anastomosis staple device 100 of FIG. 1. The anchormember 238 of the anastomosis staple device 237 may be formed from apiece of sheet metal, similarly to the other alternate embodimentspreviously described. The anchor member 238 has a distal plate 239 whichmay be flat or curved to match the exterior curvature of the targetvessel 150. Multiple attachment legs 240 are cut from the plate material239, sharpened at the ends 241, and bent with a first section 242 thatangles upwardly from the plate 239 and a second section 243 that isangled downward to pierce the target artery wall, as shown in phantomlines 243′ in FIG. 20. Preferably, the second section 243 is curved witha radius of curvature approximately equal to the length of the firstsection 242. A tubular proximal extension 244 with a slight hourglassshape extends from the distal plate 239 of the anchor member 238.

[0140] The coupling member 245 of the anastomosis staple device 237,shown in FIG. 20, is made in a tubular shape of a biocompatibleresilient material such as plastic, rubber or a springy metal, such as anickel-titanium alloy. The tubular coupling member 245 has a slighthourglass shape in axial cross section, matching the interior shape ofthe tubular proximal extension 244 of the anchor member 238. If desired,the tubular coupling member 245 can be made with slightly thickenedproximal 246 and distal 247 extremities which act as O-rings moldedintegrally with the wall of the tube. The tubular coupling member 245can be made with a continuous tubular wall or with a longitudinal slotin the wall of the tube to increase the resiliency of the couplingmember. Alternatively, the tubular coupling member 245 can be made of acoiled spring with an hourglass shape in axial cross section.

[0141] As with the previously described embodiments, the anchor member238 can be applied to the exterior of the target vessel 150 eitherbefore or after an opening 152 has been created with a vessel punch. Toplace the anchor member 238, the plate 239 of the anchor member 238 ispressed against the exterior surface of the target vessel 150 at theanastomosis site and the attachment legs 240 are pressed to drive thesharpened tips 241 through the target vessel wall 150. If an opening 152has not yet been made in the target vessel wall 150, a vessel punch isinserted through the lumen 244 of the proximal tubular extension 244 tocreate an opening 152 in the wall 150 concentric with the tubularextension 244.

[0142] Meanwhile, the graft vessel 148 is prepared by placing it throughthe lumen of the tubular coupling member and everting the end 192 of thegraft vessel 148 over the outside of the coupling member 245. Tocomplete the anastomosis, the coupling member 245 with the end 192 ofthe graft vessel 148 attached is collapsed or folded and inserted intothe proximal tubular extension 244 of the anchor member 238. Theresilience of the coupling member 245, combined with the matchinghourglass shapes of the two parts of the staple device, locks the partstogether to form a leak-proof anastomosis.

[0143] The coupling member 245 can be dimensioned so that the distal endof the coupling member 245 extends through the opening 152 in the targetvessel wall and the everted edge 192 of the graft vessel 148 sealswithin the opening 152, as illustrated, or against the interior surfaceof the target vessel 150 similarly to the one-piece embodiment of theanastomosis staple device illustrated in FIG. 9.

[0144] Alternatively, the coupling member 245 can be shaped so that itpresses the everted edge 192 of the graft vessel 148 against theexterior surface of the target vessel 150 to create a leak-proof sealsimilar to the embodiment of FIG. 1.

[0145] In a further aspect of the invention, an anastomosis fitting isprovided for rapidly and reliably creating an end-to-side anastomosisbetween a graft vessel and a target vessel, a first representativeembodiment of an anastomotic fitting 250 according to this second aspectof the present invention is shown in FIGS. 21A-21C. The anastomoticfitting 250 is made up of two coacting parts: a) a tubular inner sleeve251 which has an internal lumen 252 of sufficient size to accommodatethe external diameter of the graft vessel 254 and an inner flange 253which is attached or formed at the distal end of the sleeve 251 so as tobe positioned within the lumen 256 of the target vessel 255, and b) anouter flange 260 which has a central orifice 261 that is sized to fitover the exterior of the inner sleeve 251 to be positioned against theexterior surface 258 of the target vessel wall 255. The anastomoticfitting 250 is thus held in place by compressing the target vessel wall255 between the inner 253 and outer 260 flanges. An adjustable lockingmechanism 262 holds the outer flange 260 on the inner sleeve 251 at aselected position to create a tailored degree of tissue compression atthe anastomotic site. The anastomosis fitting 250 can be made of variousbiocompatible materials, such as stainless steel, titanium alloys,plastic, pyrolytic carbon, etc, additionally, biocompatible coatingscould be applied to the inner and/or outer surfaces of the fitting 250to increase its acceptance by the body tissues or to reduce thrombosis.

[0146] The inner sleeve 251 is a tubular member with an internal lumen252 large enough to accommodate the external diameter of the graftvessel 254, either a natural graft vessel or an artificial graft vessel.Natural saphenous vein autografts typically have an internal diameterbetween 3 mm and 10 mm and an external diameter between 4 mm and 11 mm.Pedicled arterial grafts, such as the internal mammary artery or thegastroepiploic artery typically have an internal diameter between 2 mmand 7 mm and an external diameter between 3 mm and 8 mm, with thicker,more muscular walls. Artificial prosthetic graft vessels, made ofmaterials such as Dacron or Goretex, typically have a diameter of 3 mmto 30 mm. The tubular inner sleeve 251 should be made of a rigidbiocompatible material, such as stainless steel, titanium alloys or arigid biocompatible plastic. The wall thickness of the sleeve ispreferably about 0.2 mm to 2.0 mm.

[0147] The distal end of the inner sleeve is flared at an angle ofapproximately 45 to 75 degrees to form a conical inner flange 253. Theinner flange 253 has an outer diameter of approximately 1.3 to 2.5 timesthe inner diameter of the inner sleeve 251. The use of a conical orrounded inner flange 253 helps to improve the hemodynamic efficiency ofthe anastomosis connection by improving the orifice coefficient at theentrance to the graft vessel 254. It also assures that the finishedanastomosis will not protrude into the lumen 246 of the target vessel255 or upset the hemodynamic flow in that vessel. The exterior of thetubular inner sleeve 251 has a series of circumferential ridges 263 orthreads which may be saw-tooth in shape.

[0148] The outer flange 260 as a central orifice 261 which is sized tofit over the exterior of the tubular inner sleeve 251. The outer flange260 has an outer diameter of approximately 1.3 to 3.0 times the innerdiameter of the inner sleeve 251, a ratchet mechanism 264 within oradjacent to the central orifice 261 of the outer flange 260 engages thecircumferential ridges 263 on the exterior of the tubular inner sleeve251. The ratchet 264 can be strictly a one-way mechanism so that theouter flange 260 can only move in the direction of the inner flange 253or a release mechanism can be incorporated so that the outer flange 260can be moved away from the inner flange 253 in case of prematureactivation of the ratchet mechanism 264. Alternatively, the outer flange260 could be threaded to the exterior of the tubular inner sleeve 251.The distal edge 265 of the outer flange 260 may incorporate a pluralityof attachment spikes 266 that engage and hold the wall of the targetvessel 255 and/or the everted wall 259 of the graft vessel 254 when theouter flange 260 is applied. In the preferred embodiment which isintended for creating an anastomosis between a coronary artery bypassgraft and the ascending aorta, the outer flange 260 has 4 to 12 spikesof 1 to 3 mm length and 0.2 to 0.5 mm diameter. Variations of thisconfiguration may be made where appropriate for different graft vesselsand target vessels.

[0149] The anastomosis is performed by passing the end 259 of the graftvessel 254 through the inner lumen 252 of the tubular inner sleeve 252until the end of the vessel extends a short distance from the distal endof the sleeve, as shown by phantom lines 259′ in FIG. 21A. The end 259of the graft vessel 254 is then everted over the conical inner flange253 of the fitting 250 to form an atraumatic attachment, as shown inFIG. 23A. If desired, a loop of suture can be tied around the evertedend 259 of the graft vessel 254 to hold it in place on the inner flange253 and/or the tubular inner sleeve 251. The conical inner flange 253and the everted end 259 of the graft vessel 254 are then passed throughan opening 267 that has previously been made in the wall of the targetvessel 255 with an instrument such as a vessel punch, as shown in FIG.21B. The diameter of the opening 267 in the target vessel wall ispreferably about the same as the external diameter of the tubular innersleeve 251. The opening 267 may need to stretch slightly to allow theconical inner flange 253 to pass through. The elastic recovery of thetarget vessel wall 255 around the opening 267 helps to create ananastomotic seal by contracting around the inner sleeve 251 and theeverted graft vessel wall 259. The outer flange 260 is then slid ontothe proximal end of the inner sleeve 251. If the anastomosis beingperformed is the first anastomosis of a free graft, such as a saphenousvein graft, with the other end of the graft unattached, then the outerflange 260 can be slid over the graft vessel 254 from the free end. Ifthe other end of the graft vessel 254 is not free, such as whenperforming a second anastomosis or a distal anastomosis on a pedicledgraft like the IMA, then the outer flange 260 should be back loaded ontothe graft vessel 254 or preloaded onto the proximal end of the innersleeve 251 before the end 259 of the graft vessel 254 is attached to theinner flange 253 of the fitting 250. The outer flange 260 is slid downthe inner sleeve 251 until it contacts the exterior wall 258 of thetarget vessel 255 and a desired degree of compression of the targetvessel wall 255 is applied between the inner 253 and outer 260 flanges.The ratchet mechanism 264 of the outer flange 260 locks the flange 260in place on the tubular inner sleeve 251 to complete the anastomosis, asshown in FIG. 21 C.

[0150] FIGS. 22A-22D show an anastomosis fitting 268 which is avariation of the embodiment of FIGS. 21A-21C. In this variant the innerflange 269 has a flat annular configuration, rather than a conical shapeas in the previously described embodiment. To insure that the completedanastomosis does not protrude into the blood flow lumen 256 of thetarget vessel 255, the outer flange 270 of the fitting is concave on itsdistal surface 271. The central orifice 272 of the outer flange 270tapers proximally to a locking ring 273 within the central orifice 272that slips over and locks with a collar 274 on the proximal end of thetubular inner sleeve 275. As shown in FIG. 22C, when the outer flange270 is applied to the exterior surface 258 of the target vessel 255 andlocked onto the collar 274 of the tubular inner sleeve 275, the innerflange 269 is drawn into the concave outer flange 270, so that theanastomosis is flush with or recessed into the inner wall 257 of thetarget vessel 255. This helps to assure a hemodynamically correct inflowat the entrance to the graft vessel 254. Two or more collars 274 may beprovided on the tubular inner sleeve 275 to allow adjustable compressionby the anastomotic fitting 268.

[0151] FIGS. 23A-23D show another variant 276 of the embodiment of theanastomosis fitting of FIGS. 21A-21C and FIGS. 22A-22D. In this variantthe concave outer flange 277 has a simple central orifice 278 without alocking ring. The locking mechanism is provided by multiple downwardlyoriented tangs 279 or tapered ridges, which have been formed in thesidewall of the tubular inner sleeve 280 by cutting, punching ormolding. The outer flange 277 is slid over the proximal end of the innersleeve 280 and over the tangs 279, which engage the proximal end of theouter flange 277 to lock the outer flange 277 into place on the innersleeve 280, as illustrate in FIG. 23C. If desired, multiple parallelrows of tangs 279 can be provided at different axial locations on theinner sleeve 280 to accommodate different thicknesses of the targetvessel wall 255 and to provide a tailored degree of tissue compressionat the anastomosis site. Optionally, the underside of the outer flange277 may have a plurality of attachment points which engage and hold thetarget vessel wall 255 near the opening 267 in it, adding security tothe anastomosis attachment without piercing the target vessel wall 255.

[0152] FIGS. 23A-23D also illustrate a variation of the method forapplying the anastomosis fitting. In this embodiment, the methodincludes applying a suture 281 to the everted end 259 of the graftvessel 254 to secure it to the inner flange 282. As best seen in the topview FIG. 23D, the everted end 259 of the graft vessel 254 has beensecured to the inner flange 282 of the fitting by making a runningstitch around the end of the graft vessel with a suture 281 on the backof the inner flange 282 and tying it to create a purse string that holdsthe end 259 of the graft vessel 254 in place.

[0153] A second representative embodiment of an anastomotic fitting 283employing inner 284 and outer 285 flanges has an expanding inner flange284 which facilitates the atraumatic attachment of the graft vessel 254to the fitting 283 and makes it easier to pass the inner flange 284 andthe everted graft vessel 259 through the opening 267 in the targetvessel wall 255. Two variations of such an expanding inner flange areshown in FIGS. 24A-24D and FIGS. 25A-25H. The graft vessel 254 is passedthrough an internal lumen 287 of an inner sleeve 286 which has theexpandable inner flange 284 attached at its distal end. The end 259 ofthe graft vessel 254 is everted over the unexpanded inner flange 284′.The inner flange 284′ and the everted end 259 of the graft vessel 254are passed through the opening 267 in the target vessel wall 255. Oncethe inner flange 284′ of the fitting 283 is in the lumen 256 of thetarget vessel 255, it is expanded to a diameter 284 which issignificantly larger than the opening 267 in the target vessel wall 255.Then an outer flange 285 is applied and locked into a selected positionon the inner sleeve 286 as described above to complete the anastomosis.

[0154] In the first variant of the expanding inner flange 284, shown inFIGS. 24A-24D, the flange 284 and a portion of the inner sleeve 286 areslotted to create multiple fingers 288 which are initially collapsedinward toward the center of the inner sleeve 286. The ends of thefingers form sector-shaped sections 289 of the flange 284, as seen inthe distal end view of FIG. 24D. When the flange 284 is collapsed inward284′, as in FIG. 24C, the sectors 289 fit together to form a smallerdiameter flange 284′ with a passage 287′ through the center large enoughfor a collapsed graft vessel 254 to fit through. A tubular former 290 isslidably received within the slotted inner sleeve 286 and has an axiallumen 291 large enough to receive the graft vessel 254. The tubularformer 290 initially resides in a proximal position, as shown in FIG.24A. The tubular former 290 has a ridge 292 at its proximal end thatpositions the tubular former 290 in the correct location with respect tothe inner sleeve 286 when the tubular former 290 is in its distal,deployed position. An outer flange 285, with a concave distal surface293 may be permanently attached to the inner sleeve 286 proximal to theexpanding inner flange 284. Alternatively, the outer flange 285 can beprovided as a separate component which is attached to the inner sleeve286 after the graft vessel 254 has been attached or at the end of theanastomosis procedure.

[0155] In operation, the graft vessel 254 is inserted through the axiallumen 291 of the tubular former 290 and through the internal lumen 287of the slotted inner sleeve 286 and through the central opening 287′between the collapsed sectors 289′ of the inner flange 284′. The end 259of the graft vessel 254 is everted over the collapsed sectors 289′ ofthe flange 284′. The collapsed flange 282′ and the everted end 259 ofthe graft vessel 254 are inserted through the opening 267 in the targetvessel 255. Then, the tubular former 290 is slid distally within theslotted inner sleeve 286. The tubular former 290 forces the fingers 288outward, expanding the flange 284 within the target vessel 255. If theouter flange 285 is already attached to the inner sleeve 286 at thispoint, the distal surface 283 of the outer flange 285 is pressed againstthe exterior surface 258 of the target vessel 255 as the expandableinner flange 284 is being deployed to complete the anastomosis. If, onthe other hand, the outer flange 285 has been supplied as a separatecomponent, the outer flange 285 is slipped over the proximal end of theinner sleeve 286 after the expandable inner flange 284 has been deployedand a desired degree of tissue compression is applied between the inner284 and outer 285 flanges of the fitting 283 to complete theanastomosis, as shown in FIG. 24B.

[0156] A second variant of the anastomotic fitting 294 with an expandinginner flange 298 is shown in FIGS. 25A-25H. The inner sleeve 295 of thefitting 294 is slotted along its entire length to form multiple fingers296 that are oriented essentially longitudinally to the inner sleeve295. A collar 297 on the proximal end of the slotted inner sleeve 295joins the multiple fingers 296 together in a tubular configuration. Aconcave outer flange 299 is captured on the slotted inner sleeve 295 bythe proximal collar 297. As seen in the end view in FIG. 25E, the insidediameter of the collar 297 has notches 301 which are extensions of theslots 300 between the fingers 296 of the inner sleeve 295, each of thefingers 296 has a bend 302 in it to predispose it to bend outward at themiddle when contracted longitudinally. A tubular forming tool 303 forexpanding the inner flange 298 is slidably received within the slottedinner sleeve 295. The distal end of the tubular forming tool 303 iscrenellated with multiple radially extending tabs 304. The multipleradially extending tabs 304, as seen in the end view in FIG. 25F, areconfigured to fit through the notches 301 in the collar 297 and into theslots 301 of the inner sleeve. The tubular forming tool 303 is insertedinto the slotted inner sleeve ′95 by aligning the radially extendingtabs 304 with the notches 301 in the collar 297 and sliding it distallyalong the slots 300 until the tabs 304 pass the distal ends 305 of thefingers 296. Then, the tubular forming tool 303 is rotated slightly sothat the radially extending tabs 304 engage the distal ends 305 of thefingers 296 of the slotted inner sleeve 295, as shown in FIG. 25A.

[0157] The anastomosis is performed by passing the graft vessel 254through the internal lumen of the forming tool 303 within the slottedinner sleeve 295 and everting it 259 over the distal ends 305 of thefingers 296. A loop of suture 306 can be used to hold the everted vessel259 in place. The fingers 296 of the fitting 294 and the everted end 259of the graft vessel 254 are inserted through an opening 267 in thetarget vessel wall 255. When the tubular forming tool 303 is slidproximally with respect to the slotted inner sleeve 295, the radiallyextending tabs 304 of the tubular forming tool 303 bear against thedistal ends 305 of the fingers 296 compressing them longitudinally. Thefingers 296 bow outward, folding at the bend 302 to expand and create aninner flange 298 which engages the inner surface 257 of the targetvessel wall 255. The tubular forming tool 303 is pulled furtherproximally until the newly formed inner flange is drawn into the concaveouter flange 299, compressing the target vessel wall 255 and recessingthe inner flange 298 and the anastomotic connection into the targetvessel wall 255, as shown in FIG. 25D. The tubular forming tool 303 cannow be removed by rotating it with respect to the slotted inner sleeve295 so that the tabs align with the slots 300 and withdrawing it fromthe fitting 294. The mass of foreign material that is left as an implantat the anastomotic site is thus reduced.

[0158] Alternatively, the inner sleeves 295 and the tubular forming tool303 can be formed integrally or welded together as one piece, in whichcase both the inner sleeve 295 and the tubular forming tool 303 wouldremain in the finished anastomosis. As a further alternative, thetubular forming tool 303 could be made to break away from the innersleeve 295 when a certain force is applied.

[0159] In a further aspect of the invention, the anastomotic fitting hasa single-piece construction with an inner sleeve that is integrallyattached to a fixed inner flange and to a deformable outer flange. Threevariants of the anastomotic fitting with a deformable outer flange andtheir forming tools are shown in FIGS. 26A-26I, 27A-27D and 28A-28I.

[0160] The first variant of the anastomotic fitting 306 with adeformable outer flange is shown in FIGS. 26A-26I. The anastomoticfitting 306 has a tubular main body 307 having an internal lumen 303sized to accommodate the external diameter of the graft vessel 254, afixed inner flange 309 is attached to the distal end of the tubular body307. On the proximal end of the tubular body 307 are a plurality ofhingedly attached outer flange segments 310. In this illustrativeembodiment, there are four such flange segments 310 which are enlargedat their outer edges to form sector-shaped segments 310 of the outerflange 311. The hinge portion 312 of each flange segment 310 is adeformable strip of metal 312 connecting the flange segment 310 to themain tubular body 307. Preferably, the tubular body 307, the innerflange 309 and the flange segments 310 of the outer flange 311,including the deformable hinge portion 312, are integrally formed of asingle piece of biocompatible metal, such as stainless steel, a titaniumalloy or a cobalt alloy (e.g. Carpenter MP35).

[0161] The distal end of a device 313 for applying the anastomosisfitting is shown in FIG. 26B. The device has an inner tubular memberknown as the anvil 314 and an outer tubular member called the driver315. The distal end of the anvil 314 has a gripper 316 for holding ontothe anastomosis fitting 306. The gripper 316 in the preferred embodimenthas a bayonet-type fitting with four L-shaped gripping fingers 317 whichhold the fitting 306 by hooking onto each of the flange segments 310 atthe deformable hinge portion 312. The driver slides 315 telescopicallyover the outside of the anvil 314 and has an annular driving surface 318on its distal end configured to engage the outer ends of each flangesegment 310. The anvil 314 and the driver 315 can be made in a longversion, approximately 15 to 30 cm in length, for performing port-accessCABG surgery or a short version, approximately 10 to 20 cm in length,for performing standard open-chest CABG surgery.

[0162] The fitting 306 is prepared for performing the anastomosis byattaching the fitting 306 to the gripper 316 on the distal end of theanvil 314. Then, the graft vessel 254 is passed through the inner lumen319 of the anvil 314 until the end 259 to be anastomosed extends a shortdistance from the distal end of the fitting 306. The end of the graftvessel 259 is everted over the inner flange 309 of the fitting to forman atraumatic attachment between the two. If the anastomosis beingperformed is part of a port-access CABG surgery procedure, the fittingon the end of the application tool is inserted into the patient's chestthrough an access port made through one of the intercostal spaces. Theinner flange 309 and the everted end 259 of the graft vessel 254 areinserted through an opening 267 that has been made in the wall of thetarget vessel 255. The fitting 306 is pulled back slightly so that theinner flange 309 is flush against the interior surface 257 of the targetvessel. Then, the driver 315 is pushed distally with respect to theanvil 314 until the driving surface 318 deforms the outer flangesegments 310 against the exterior surface 258 of the target vessel wall255 and the desired degree of compression of the vessel wall 255 isobtained. The anvil 314 is rotated slightly to release the gripper 316from the flange segments 310 of the fitting 306 and the applicationdevice 313 is withdrawn from the patient's body.

[0163] The second variant of the anastomotic fitting 320 with adeformable outer flange 321 is shown in FIGS. 27A-27D. This variant islargely the same as the first variant just described in connection withFIGS. 26A-26I with the exception of the inner flange 322 construction.In this embodiment, the inner flange 322 is slightly conical in order toprovide a more hemodynamically efficient inlet to the graft vessel 254at the anastomosis. In addition, a plurality of attachment spikes 323preferably 6 to 8 spikes, have been provided along the periphery of theinner flange 322. In a preferred configuration, the anastomotic fitting320 is fully deployed, the spikes 323 penetrate through the everted wall259 of the graft vessel 254 and into the wall of the target vessel 255to create a more secure attachment for the anastomosis. When the outerflange segments 324 are deformed against the exterior surface 258 of thetarget vessel 255 and compress the vessel wall 255 such that they engagethe spikes 323 on the inner flange 322 for a very secure attachment.

[0164] The third variant of the anastomotic fitting 325 with adeformable outer flange 326 is shown in FIGS. 28A-28I. The anastomoticfitting 325 has a tubular main body 327 with an internal lumen 328 sizedto accommodate the external diameter of the graft vessel 254. The wallsof the tubular body 327 have a pair of L-shaped slots 329 that are openat the top of the tubular body 327 to form a bayonet fitting. An innerflange 330, which may be slightly conical in shape, is attached to thedistal end of the tubular body 327. Attached to the proximal end of thetubular body 327 is a deformable outer flange 326, comprising amultiplicity of axially-oriented bars 331 separated by axial slots. 332The axially-oriented bars 331 are attached at their distal ends to thetubular main body 327, and are joined at their proximal ends by a ring333 forming the proximal end of the fitting 325 The bars 331 are bentoutwardly near their centers 334 so that the bars 331 preferentiallybend outwardly when compressed. The tubular body 327, the inner flange330 and the deformable outer flange 326 are preferably machined of asingle piece of biocompatible metal, such as stainless steel, a titaniumalloy or a cobalt alloy. The geometry of this device could also beconfigured so that the bars 331 of the outer flange 326 start off almoststraight, and are deformed further to reach their final geometry.

[0165] A device 335 or applying the anastomotic fitting is shown inFIGS. 28D-F. The device 335 has an inner tubular member 336 which has apair of radially extending tabs 337 on its distal end that interlockwithin the L-shaped slots 329 in the tubular body 327 of the fitting325. An outer tubular member 338, the pusher 338, slides telescopicallyover the outside of the inner tubular member 336 and has an annulardriving surface 339 on its distal end. This anastomosis fittingapplication device 335 can be made in a long version for port-accessCABG surgery or a short version for standard open-chest CABG surgery.

[0166] The fitting 325 is prepared for performing the anastomosis byattaching the anastomotic fitting 325 to the inner tubular member 336.Then, the graft vessel 154 is passed through the inner lumen 340 of theinner tubular member 336 until the end 159 to be anastomosed extends ashort distance from the distal end of the fitting 325. The end 159 ofthe graft vessel 154 is everted over the inner flange 330 of the fitting325 to form an atraumatic attachment, as shown in FIG. 28D. If theanastomosis being performed is part of a port-access CABG surgeryprocedure, the fitting 325 on the end of the application tool 335 isinserted into the patient s chest through an access port made throughone of the intercostal spaces. The inner flange 330 and the everted end159 of the graft vessel 154 are inserted through an opening 267 that hasbeen made in the wall of the target vessel 225, as shown in FIG. 28E.The fitting 325 is pulled back slightly so that the inner flange 330 isflush against the interior surface 257 of the target vessel 255. Then,the pusher 338 is moved distally with respect to the inner tubularmember 336 until the driving surface 339 contacts the proximal surfaceof the deformable outer flange 326. The pusher 338 deforms the outerflange 326 by compressing the bars 331, which bend outwardly and foldinto a flattened configuration, as shown in FIG. 28F, to form a radiallyspoked outer flange 326′. The pusher 338 further deforms the bars 331 topress the outer flange 326′ against the exterior surface 258 of thetarget vessel wall 255 and obtain the desired degree of compressionbetween the inner 330 and outer 326′ flanges. The inner tubular member336 is removed by rotating it with respect to the fitting 325 andwithdrawing the tabs from the L-shaped slots 329.

[0167] A further embodiment of an anastomosis fitting 340 according tothe invention is illustrated in FIG. 29A-C. The anastomosis fitting ofFIG. 29A-C may be particularly advantageous with older patients,diabetic patients and other patients whose veins are no longer asresilient as they once were, where it may be difficult to stretch thesaphenous vein graft enough to evert it over a large inner flange. Thisis also true of many artificial graft materials that will not stretch atall to evert them over a large flange. The anastomosis fitting 340 ofFIG. 29 A-C has a tubular body member 341 with a small primary innerflange 342 attached to the distal end. Threads 343 or similar featureson the inner surface the proximal end of the tubular body member 341facilitate grasping the tubular body member 341 with an applicationinstrument. A secondary inner flange washer 344 has a central orifice345 with inwardly facing tabs 346 configured to engage the primary innerflange 342, as seen in distal end view 29C. An outer flange 347 isconfigured to slide over the proximal end of the tubular body 341 and islocked in place by a self-locking retaining washer 348 with upwardlyinclined tabs 349 that frictionally engage the outer surface of thetubular body 341, allowing the outer flange 347 to slide in the distaldirection with respect to the tubular outer body 341, but not in theproximal direction. The outer flange 341 may have a plurality ofattachment spikes 350 on its distal surface to penetrate the outer wall258 of the target vessel 255.

[0168] In operation, first the outer flange 347 with its retainingwasher 348 and then the secondary inner flange washer 344 are backloaded onto the holder 352 of the application device 351. Next, thetubular body 341 is threaded onto the distal end of the holder 352. Thegraft vessel 254 is passed through the internal lumen 353 of theapplication instrument 351 and the distal end 259 of the graft vessel254 is everted over the small primary inner flange 342 of theanastomosis fitting 340. The secondary inner flange washer 344 is thenslid distally so that it bears against the proximal face of the innerflange 342, as shown in FIG. 29A. The primary inner flange 342, with theeverted graft vessel 259 attached, and the secondary inner flange washer344 are inserted through an opening 267 that has been made in the targetvessel wall 255 as shown in FIG. 29A. A slight tension is exerted on theapplication instrument 351 to seat the primary inner flange 342 and thesecondary inner flange washer 344 against the interior surface 257 ofthe target vessel wall 255 and the driver 354 is advanced distally topress the outer flange 347, with its self-locking retaining washer 348,onto the exterior of the tubular body member 341 until the desireddegree of compression between the inner 242, 344 and outer flanges isobtained. The holder 352 is disengaged from the tubular body member 341and the entire application instrument 351 is withdrawn from the body.

[0169] A distal end view of the completed anastomosis is shown in FIG.29C. The larger diameter of the secondary inner flange washer 344 addsto the security of the anastomosis attachment, while it does not requirethe graft vessel 254 to be stretched to fit over a large inner flange.Only a very small amount of foreign material is exposed within thetarget vessel lumen and it is spaced a short distance from the actualanastomosis site which may reduce the likelihood of complications.Because the secondary inner flange 344 washer only contacts the primaryinner flange 342 and the everted graft vessel wall 259 at four smallpoints, it will not interfere with the intima-to-intima approximation ofthe graft vessel 259 and the target vessel 255 which is preferred inorder to promote endothelialization of the anastomosis site.

[0170] FIGS. 30A-30F illustrate an embodiment of the anastomosis fitting355 of the present invention which combines an inner tubular member 356having deformable attachment legs 357 at its distal end, with an outerflange 358. The deformable attachment legs 357 have an initial position357 allowing the graft vessel 254 to be easily everted over andpenetrated by the attachment legs 357. The attachment legs 357 aresubsequently deformed to a deployed position 357′ wherein the attachmentlegs 357′ perform the function of the inner flange in many of theabove-described embodiments by engaging the interior surface 257 of thetarget vessel 255 and compressing the tissue between the attachment legs357′ and the outer flange. 358 The inner tubular member 356 is shown inFIG. 30A. The tubular member 356 is preferably made from a biocompatiblemetal, such as an alloy of stainless steel, titanium or cobalt. Thetubular member 356 has an internal lumen 359 of sufficient size toaccommodate the external diameter of the graft vessel 254. The tubularmember 356 is made with a plurality of attachment legs 357 extendingaxially from its distal end 360. This illustrative embodiment is shownwith four attachment legs 357. Other exemplary embodiments may have fromthree to twelve attachment legs 357 depending on the sizes of the graftvessel 254 and target vessel 255 to be joined. The attachment legs 357preferably have a width of approximately 0.5-2.0 mm, more preferablyabout 1.0 mm, and a thickness of approximately 0.1-0.5 mm, morepreferably about 0.25 mm. The width and thickness of the attachment legs357 is chosen so that the legs 357 will be relatively rigid when theyare in their deployed position 357′, yet they are still easily deformedusing the special forming dies 369, 370, 371 provided with theanastomosis system. The distal ends 361 of the attachment legs 357 aresharpened to easily penetrate the walls of the graft vessel 254 andtarget vessel 255. The exterior surface of the tubular member 256 may bemade with a groove or slot 362 around its circumference as a detent forthe outer flange 358 spaced a calculated distance from the distal end360 of the tubular member 356 to provide a desired degree of compressionon the anastomosis when the outer flange 358 locks into the groove. 362A plurality of holes 363 through the wall of the tubular member 356(three holes 363 in this illustrative embodiment) are located near theproximal end of the tubular member 356 to facilitate grasping the device355 with an application instrument 372.

[0171] The outer flange 358, illustrated in FIG. 30B, has a centralorifice 364 which is sized to fit over the exterior of the tubularmember 356. The outer flange 358 has a locking mechanism, which includesa self-locking retaining washer 365 with upwardly inclined locking tabs366 integrally formed with the outer flange, 358 to slidably positionthe outer flange 358 on the exterior surface of the tubular member 356.Alternatively, the self-locking retaining washer 365 can be manufacturedseparately and attached to the outer flange 358 The upwardly inclinedlocking tabs 366 allow the retaining washer 365 to slide in the distaldirection over the exterior of the tubular member 356, but resistsliding in the proximal direction. When the upwardly inclined lockingtabs 366 lock into the groove 362 in the exterior surface of the tubularbody 356 it forms a more permanent attachment, strongly resistingmovement in the proximal direction. Other locking mechanisms can also beused for positioning the outer flange 358 with respect to the tubularmember 356, such as ratchet mechanisms, detents, or releasable lockingdevices. The distal surface 367 of the outer flange 358 is configured tocontact the exterior surface 258 of the target vessel 255. Preferably,the distal surface 367 of the outer flange 358 is slightly concave, asillustrated. If desired, the outer flange 358 may be made with shortspikes extending from its distal surface. The outer periphery of theouter flange 358 is perforated with a series of holes 368, which arepositioned to be aligned with the distal ends 361′ of the attachmentlegs 357′ of the tubular member 356 when the fitting 355 is fullydeployed. Making the holes 368 in a multiple of the number of attachmentlegs 357, as in the present example which has eight holes 368,corresponding with four attachment legs 357, facilitates aligning theholes 368 with the distal ends 361′ of the attachment legs 357′. Theouter flange 358 is preferably made from a biocompatible metal, such asan alloy of stainless steel, titanium or cobalt or a biocompatiblepolymer, alternatively, a separate locking washer 365 made from abiocompatible metal can be joined to an outer flange 358 made of apolymer or other biocompatible material.

[0172] The anastomosis fitting 355 is part of a complete anastomosissystem for forming and applying the anastomosis fitting 355 to create anend-to-side anastomosis. A set of three forming dies 369, 370, 371 areconfigured to deform the attachment legs 357 of the anastomosis fitting355 from their initial position 357 to a deployed position 357′, and aspecialized grasping tool 372 is used to insert the deployed innertubular member 356 through an opening 267 in the side wall of the targetvessel 355. These tools, which will be described in more detail in theoperational description below, facilitate the rapid and repeatabledeployment of the anastomosis fitting 355 with a minimum of manualmanipulation required.

[0173] In operation, the end-to-side anastomosis procedure is performedusing the anastomosis fitting 355 by first preparing the free end 259 ofthe graft vessel 254 for attachment. If the anastomosis being performedis a second anastomosis or is being performed on the free end of apedicled graft, the outer flange 358 must first be back-loaded onto thegraft vessel 254 with the distal surface 367 facing the end 259 of thevessel to be attached. If the anastomosis is being performed as thefirst anastomosis on a free graft, the outer flange 358 can bebackloaded onto the graft vessel 254 at this time or it can be passedover craft vessel 254 from the far end at a later point in theprocedure, whichever is preferable. Next, the free end 259 of the graftvessel 254 is passed through the internal lumen 359 of the inner tubularmember 356 so that it extends a short distance from the distal end 360of the tubular member 356, as shown in FIG. 30C. The free end 259 of thegraft vessel 254 is everted and the attachment legs 357 are piercedthrough the everted wall 259 of the graft vessel 254 to prepare thegraft vessel 254 as shown in FIG. 30D. If desired, a loop of suture canbe tied around the everted end 259 of the graft vessel 254 to helpsecure the graft vessel 254 in its everted position over the exteriorsurface of the tubular member 356.

[0174] After piercing the graft vessel wall 259, the attachment leas 357of the tubular member 356 are deformed from their axially extendingposition 357 by first bending them outward so that they extend radiallyfrom the distal end 360 of the tubular member 356, then bending thedistal ends 361′ of each of the attachment legs 357′ so that they aredirected proximally with respect to the tubular member 356, as shown inFIG. 30E. For a typical application of the anastomosis fitting 355 inmaking an end-to-side anastomosis between a saphenous vein graft and theascending aorta, the radially extending portion 373 of each deployedattachment leg 357′ is about 3-4 mm long, and the proximally directeddistal portion 374 of each deployed attachment leg 357′ is about 2-5 mmlong. These dimensions will vary somewhat depending on the size and thewall thickness of the graft vessel and the target vessel to be joined.

[0175] A set of three forming dies 369, 370, 371 are provided forrapidly and repeatably forming the anastomosis fitting 355 into thedeployed position shown in FIG. 30E. The first die 369 is cylindrical inshape with a counterbored recess 375 on one end which is sized to holdthe proximal end of the tubular member 356 of the anastomosis fitting,an annular forming surface 376 on the end of the die 369 surrounds thecounterbored recess 375, an annular space 377 between the counterboredrecess 375 and the annular forming surface 376 provides sufficientclearance for the everted end 259 of the graft vessel 254 when the innertubular member 356 of the anastomosis fitting 355 is inserted into thecounterbored recess 375. The proximal end of the graft vessel 354extends through a central lumen 378 in the first die 369 and exits thedie through a notch 379 in the far end of the die 369 which communicateswith the lumen 378. The second die 370 has a conically tapered end 380which is used to initiate the outward bend of the attachment legs 357 bypressing the tapered end 380 between the attachment legs 357, as shownin FIG. 30G. The third die 371 is cylindrical in shape with acounterbore 381 on one end that is sized to fit over the outside of thefirst die 369 with a radial clearance sufficient for the thickness ofthe attachment legs 357′. There is a forming shoulder 382 within thecounterbore 381 of the third die 371, and there is a tapered edge 383leading into the counterbore 381. The third die 371 is placed over thedistal end of the inner tubular member 356 after the attachment legs 357have been bent outward by the second die 370. As the counterbore 381 ofthe third die 371 slides over the exterior of the first die. 369 theradially extending portion 373 of the attachment legs 373 are formedbetween the forming shoulder 382 of the third die 371 and the annularforming surface 376 of the first die 369 and the proximally extendingportion 374 of the attachment legs 357′ is formed between the exteriorof the first die 369 and the counterbore 381 of the third die 371, asshown in FIG. 30H.

[0176] The tubular member 356 of the anastomosis fitting 355, which hasbeen formed to its deployed position, is withdrawn from the first die369 and is grasped with the special grasping tool 372. The grasping tool372 has expandable jaws 384, 385 which fit between the graft vessel 354and the inner lumen 359 of the tubular member 356. The jaws 384, 385 areshaped like sectors of a cylinder with an exterior diameterapproximately equal to the inner diameter of the tubular member 356,each of the sectors is somewhat smaller than a semi-cylinder so that thejaws 384, 385 can be collapsed small enough to easily fit within theinternal lumen 359 of tubular member 357. A thumbscrew, or othersuitable mechanism, on the grasping tool 372 expands the jaws 384, 385so that they bear against the interior surface of the tubular member356. Lugs 386 corresponding to the three holes 363 in the proximal endof the tubular member 356 engage the three holes 363 to enhance thegrasping tool's grip on the tubular member 356.

[0177] Using the grasping tool 382, the bent attachment legs 357′ andthe distal end 360 of the tubular member, with the everted end 259 ofthe graft vessel 254 attached, are inserted through an opening 267 inthe target vessel wall 255 that has previously been made with an aorticpunch or similar instrument, as shown in FIG. 30I. The opening 367 ispreferably made so that it is approximately the size of the externaldiameter of the tubular member 356 to provide compression around theeverted end 259 of the graft vessel 254 to help create an anastomoticseal. Since the opening 267 is slightly smaller than the diameter of thebent attachment legs 357′, the opening 267 must be stretched slightly toallow the attachment legs 357′ to pass through the opening 267.Insertion can be effectively accomplished by passing two of theattachment legs 357′ through the opening 267 in the target vessel wall255, then gently stretching the opening 267 with forceps to insert theremaining attachment legs 357′.

[0178] Once the attachment legs 357′ have been passed through theopening 267 in the target vessel wall 255, the inner tubular member 356is pulled back with enough force to cause the sharpened distal ends 361′ of the attachment legs 357′ to pierce the interior surface 257 of thetarget vessel wall 255. This action also serves to approximate theeverted end 259 of the graft vessel 254 with the interior surface 257 ofthe target vessel 255 to effect the desired intimal surface-to-intimalsurface approximation between the two vessels. The sharpened distal ends361′ of the attachment legs 357′ can be assisted in piercing the targetvessel wall 255 by pressing on the exterior 258 of the target vesselwall 255 with an elastomeric-tipped probe while maintaining some tensionon the tubular body 356 of the fitting using the grasping tool 372. Theanastomosis is completed by sliding the central orifice 364 of the outerflange 358 over the exterior surface of the tubular member 356 andmoving the outer flange 358 distally while keeping some tension on thetubular member 356 to create tissue compression at the anastomosis siteto assure an anastomotic seal. A probe 387 with a distal pushing surface388 can be used to press the outer flange 358 onto the tubular member356. The distal pushing surface 388 of the probe 387 is slotted andangled so that it can be used from the side of the grasping tool 372.The proximally directed distal ends 361′ of the attachment legs 357′pass through the holes 363 around the periphery of the outer flange 358,as shown in FIG. 30J. If desired, the distal surface 367 of the outerflange 358 can be made somewhat concave to help create a hemodynamicallyefficient transition between the target vessel lumen 256 and the graftvessel lumen 249. The self-locking retaining washer 365 of the outerflange 358 locks into the circumferential groove 362 on the exterior ofthe tubular member 356 to permanently hold the outer flange 358 in afixed position relative to the tubular member 356.

[0179]FIG. 31A shows a further embodiment of an anastomosis device 390according to the invention that combines a fastening flange 391 with aplurality of staple members 392. The device 390 includes a fasteningflange 391 which has a central orifice 393 of sufficient size toaccommodate the external diameter of the graft vessel 254. The externaldiameter of a saphenous vein graft used in CABG surgery can range from 3to 10 mm. The fastening flange 391 and the central orifice 393 can bemade circular, as shown in FIG. 31B, for making a typical right angleanastomosis. Alternatively, the fastening flange 391 and/or the centralorifice 393 can be made elliptical, oval, egg-shaped or tear dropshaped, as shown in FIGS. 31C and 31D, for making a more hemodynamicallyefficient angled Anastomosis. Many of the anastomotic fittings andstaples described herein lend themselves to noncircular configurations,such as elliptical or teardrop shapes, each of the detailed descriptionsof the various embodiments should be assumed to include noncircularflanges as an optional configuration. The fastening flange 391 is madewith a distal surface 394 over which the free end 259 of the graftvessel 254 is everted, as shown in FIG. 31A. The fastening flange 391can be made with an annular ridge 395 or with other features on itsouter surface to help attach the everted end 259 of the graft vessel 254to the flange 391. The distal surface 394 of the fastening flange 391may be contoured to provide a close fit between the everted edge 259 ofthe graft vessel 254 and the exterior wall 258 of the target vessel 255.If the target vessel 254 diameter is very large compared to the diameterof the graft vessel 254, as in a coronary artery bypass graft toascending aorta anastomosis, then a planar distal surface 394 on thefastening flange 391 may sufficiently approximate the exterior surface258 of the target vessel 255. However, if the craft vessel 254 diameteris closer to the diameter of the target vessel 255, as in a bypass graftto coronary artery anastomosis, then the fastening flange 391 should bemade with a cylindrical or saddle-shaped contour on the distal surface394 that closely approximates the exterior contour of the target vessel255. The fastening flange 391 should be made of a biocompatible materialsuch as stainless steel, titanium alloys, or a biocompatible polymer.The fastening flange 391 acts as an external stent which holds theanastomosis site open and patent, so the flange material is preferablyrigid or at least sufficiently resilient to hold its intended shape.

[0180] The fastening flange 391 with the everted end 259 of the graftvessel 254 attached to it is fastened to the exterior wall 258 of thetarget vessel 255 with the central orifice 393 aligned with an opening267 in the target vessel wall 255 that has been previously made using avessel punch or similar instrument. The fastening flange 391 is held inplace by a plurality of fastening members 292, which in this embodimenttake the form of metallic surgical staples 292 which are shown in FIG.31E. The surgical staples 292, preferably 4-12 of them arranged aroundthe periphery of the fastening flange 391, traverse from the proximalside 396 to the distal side 394 of the flange 391, then pierce theeverted graft vessel wall 259 and the wall of the target vessel 255. Itis preferable that the staples 292 pass through premade holes 397 in thefastening flange 391, however, if the fastening flange 391 is made of aresilient material, the staples 392 may pierce the flange 391 as theypass through it. The distal ends 398 of the staples 392 are deformed bya forming device or anvil against the interior surface 257 of the targetvessel wall 255 to hold the device in place to complete the anastomosis.

[0181] The staples 392 can be specially constructed so that they willdeform at the appropriate point on the attachment legs 399. One way toachieve this desired result is to make the core 400 of the staple 392,including the crossbar 401 and the two attachment legs 399, of a softdeformable metal such as annealed stainless steel. A proximal portion ofeach of the attachment legs 399 is surrounded by a stiffening sleeve 402that is made of a more rigid material, such as hard stainless steelhypodermic tubing. The stiffening sleeves 402 prevent the proximalportion of the attachment legs 392 from deforming. The stiffeningsleeves 402 should be sized so that their length corresponds to slightlyless than the combined thickness of the flange 391, the graft vesselwall 259 and the target vessel wall 255 so that, when the attachmentlegs 399 are bent at the distal edge of the stiffening sleeves 402, atailored amount of compression is applied at the anastomotic site toensure a leak proof attachment without excessive crushing of the tissuewhich could lead to necrosis. Alternatively, the staples could bemanufactured with attachment legs 399 having a thicker cross sectionproximal portion and a thinner cross section distal portion so that theattachment legs 399 will deform at the appropriate point.

[0182] The anastomosis device 390 is part of a complete anastomosissystem that includes a specially adapted application device 403 forcreating the anastomosis. The distal end of the application device 403can be seen in FIG. 31A, a staple driver 404 pushes the staples 392 fromthe proximal end, while a specially constructed anvil 405 reaches intothe lumen 256 of the target vessel 255 to deform the distal ends 398 ofthe attachment legs 399. The staple driver 404 has an annular distalsurface 406 which presses against the crossbars 401 of the staples 392.In one embodiment, the staple driver 404 can be tubular with an internallumen 407 large enough to accommodate the graft vessel 254, allowing thegraft vessel 254 to be passed through the staple driver 404 from theproximal end to the distal end, alternatively, the staple driver 404 canbe made with a C-shaped cross section with a side opening that is largeenough to pass the graft vessel through from the side. The anvil 405 isarticulated on the distal end of an elongated shaft 408. The shaft 408is long and narrow enough to pass through the lumen 249 of the graftvessel 254 from the free end of the graft. The anvil 405 is passedthrough the graft vessel lumen 249 in an orientation axially alignedwith of the shaft 408 and, once it is in the lumen 256 of the targetvessel 255, it is articulated at 90°, as shown in FIG. 31A, acylindrical or olive-shaped centering element 409, such as an inflatablecentering balloon on the shaft 408, can be used to center the shaft 408of the anvil 405 within the lumen 249 of the graft vessel 254 and withinthe central orifice 393 of the flange 291. The anvil 305 can now berotated about the shaft 308 to deform the distal ends 398 of theattachment legs 399.

[0183] The application device 403 can operate by two differentmechanisms. It can operate in a manner similar to other surgicalstaplers by aligning the staple driver 404 and the anvil 405 on oppositeends of a staple 292, then moving them axially toward one another, bymoving either the staple driver 404 distally, or the anvil 405proximally, or a combination of the two motions. This relative movementcompresses the staple leg 399 in between the anvil 405 and the stapledriver 404 and deforms it to hold the anastomosis together, analternative mechanism involves rotating the anvil 405 with respect tothe staple driver 404 and the anastomosis device 390 like a wiper tosequentially bend over the distal ends 398 of the staples 392, as shownin FIG. 31F. The staple driver 404 may be equipped with a gripping meansfor holding the fastening flange 391 to prevent any resultant torque onthe flange 391 from being transferred to the delicate vascular tissues.Alternatively, the olive-shaped centering element 409 or balloon couldhave sufficient bearing surface that the delicate vascular tissues donot suffer any significant damage. An alternative embodiment would havetwo or more wiper anvil elements 405 spaced symmetrically about the axisof the shaft 408, so that opposing staples 392 are bent simultaneously,reducing the net torque applied to the centering element 409 and thetissues.

[0184]FIG. 32A shows another variation of the anastomosis device of FIG.31 A. This variation of the anastomosis device 410 uses preformedspring-like fastening staples 411. As in the previously describeddevice, the anastomosis device 410 includes a fastening flange 412 witha central orifice 413 of sufficient size to accommodate the exteriordiameter of the graft vessel 254. A plurality of preformed fasteningstaples 411 are arranged around the periphery of the fastening flange412. Preferably, the staples 411 are preloaded into premade axial holes414 through the fastening flange 412. The staples 411 should be made ofa highly resilient biocompatible spring material, such asspring-tempered stainless steel or titanium alloys. Superelasticmaterials, such as nickel-titanium alloys, can also be used for formingthe spring-like staples. Information about the composition and treatmentof superelastic metal alloys useful in the manufacture of the springlike staples can be found in U.S. Pat. No. 4,665,906, entitled MedicalDevices Incorporating SIM Alloy Elements, the entire disclosure of whichis hereby incorporated by reference. Two alternate forms for thespring-like staples 411, 420 are shown in FIGS. 32B and 32C. FIG. 32Bshows a single staple 411 which has one attachment leg 415. The distalend 416 of the attachment leg 415 is sharpened to easily pierce theblood vessel walls, a distal portion 417 of the attachment leg 415 isbent at an acute angle with respect to a central portion 418 of the leg415. Similarly, a proximal portion 419 of the leg 415 is bent at anacute angle with respect to the central portion 418. The proximalportion 419 and the distal portion 417 of the staple 411 can be angledin the same direction with respect to the central portion 418 to make aC-shaped staple, as shown in FIG. 32B, or the proximal 419 and distal417 portions can be angled in opposite directions to create a Z-shapedstaple. FIG. 32C shows a double staple 420 which has two parallelattachment legs 415. The distal end 415 of each attachment leg 415 issharpened to easily pierce the blood vessel walls. The distal portions417 of the attachment legs 415 are bent at an acute angle with respectto the central portions 418 of the legs 415. The proximal portions 419of the legs 415 are also bent at an acute angle with respect to thecentral portions 418. The proximal portions 419 of the attachment legs415 are linked together by a crossbar 421. The double staple 420 has anadvantage in that the crossbar 421 linking the two attachment legs 415keeps the staple 420 aligned within the fastening flange 412. When usingdouble staples 420 with the fastening flange 412, the axial holes 414through the flange 412 should be made as pairs of holes 414 spaced apartby approximately the length of the crossbar 421 of the staple 420.Similar to the single staple 411 of FIG. 32B, the double staple 420 canbe made with the proximal portions 419 and the distal portions 417 ofthe attachment legs 415 angled in the same direction with respect to thecentral portions 418 to make a C-shaped staple, when viewed from theside, or the proximal 419 and distal 417 portions can be angled inopposite directions to create a Z-shaped staple as shown in FIG. 32C.

[0185] The operation of either staple version can be understood from thesequence of drawings in FIGS. 32D, 32E, and 32F. The followingoperational description using the single staple 411 of FIG. 32B is,therefore equally applicable to the double staple 420 of FIG. 32C. Thestaples 411 are preferably preloaded into the fastening flange 412 sothat the distal bend 427 of the staple legs 415 is captured within andstraightened by the hole 414 through the flange 412. The resilience ofthe spring material prevents the staple legs 415 from taking a permanentset when they are straightened out to load them into the holes 414 inthe flange 412.

[0186] If a superelastic nickel-titanium alloy is used for thespring-like staples 411, then the shape-memory property of the alloy canbe used to facilitate loading the staples 411 into the flange 412. To dothis, the staple 411 would first be annealed in the desired shape forthe final staple. Then, the staple 411 would be plastically deformedbelow its transition temperature to straighten out the distal bend 427.The straightened staples 411 are easily inserted into the holes 414 inthe flange 412. Finally, the staples 411 are heated above theirshape-memory transition temperature to make them resume their annealedshape. Preferably, the transition temperature is below body temperatureso that the alloy of the staple 411 is in its martensitic orsuperelastic phase when the staple 411 is deployed within the body.Since the distal bend 427 is captured within the hole 414 in the flange412, it is held straight until the staple 411 is deployed in thefollowing steps.

[0187] The free end 259 of the graft vessel 254 is everted over thedistal surface 422 of the fastening flange 412, as shown in FIG. 32D,and the device 410 is aligned with an opening 267 that has beenpreviously made in the target vessel wall 255. To help align the centralorifice 413 of the flange 412 with the opening 267 in the target vessel255, an alignment device 423 can be inserted through the lumen 249 ofthe graft vessel 254 from the opposite end of the graft. The alignmentdevice 423 has a narrow, elongated shaft 424 which fits through thelumen 249 of the graft vessel 254 and an atraumatic centering element425, such as an inflatable centering balloon on the distal end of theshaft 424. The centering element 425 serves to align the central orifice413 of the flange 412 and the graft vessel lumen 249 with the opening267 in the wall of the graft vessel 255. The alignment device 425 canalso be used to apply a mild amount of traction on the target vesselwall 255 to better approximate the everted end 259 of the graft vessel254 and the target vessel 255 when making the anastomosis.Alternatively, the centering element 425 could be replaced with a vesselpunch introduced through the graft vessel lumen 249, as in theembodiments described in connection with FIGS. 2-5.

[0188] Once the everted end 259 of the graft vessel 254 and the targetvessel 255 have been properly approximated, the staple driver 426 isadvanced distally, as shown in FIG. 32E. The distal ends 416 of thestaples 411 pierce the everted graft vessel wall 259 and the targetvessel wall 255 and the distal portion 417 of the attachment legs 415traverses the vessel walls in a linear path. As the distal bend 427 ofthe attachment legs 415 exit the hole 414 in the fastening flange 412,the distal portions 417 begin to resume their acute angle bend. By thetime the staple driver 426 reaches its most distal position, the distalbend 427 of the attachment legs 415 is fully reconstituted within thelumen 256 of the target vessel 255. When the staple driver 426 iswithdrawn, the spring action of the proximal bend 428 in the attachmentlegs 415 pulls the staple 411 back slightly to embed the distal portions417 of the attachment legs 415 into the interior surface 257 of thetarget vessel wail 255, as shown in FIG. 32F. The spring action of thestaples 411 also serves to exert compressive force between the fasteningflange 412 and the target vessel wall 255 to assure a leak proof andsecure attachment.

[0189] During the manufacture of the staples 411, the distal bends 427on the staple attachment legs 415 can be made with almost any desiredorientation. The distal bends 427 can be oriented to turn the distalportion 417 of the attachment legs 415 toward the opening 267 in thetarget vessel wall 255, as shown in FIG. 32F, or the distal portions 417can be oriented pointing away from the opening 267. Alternatively thedistal portions 417 can be aligned so that they bend tangentially to theopening 267. The tangential distal portions can be oriented so that theycross one another. Perhaps more advantageously, the tangential distalportions 417 can be oriented so that they all bend in the samedirection, as shown in FIG. 32G, so that a more complete gap-free sealis made all around the periphery of the anastomosis.

[0190] FIGS. 33A-33D and 34A-34D show two variations of an anastomosisdevice 430 having a fastening flange 431 and a plurality of S-shapedstaple members 432 formed from a superelastic metal alloy such as anickel-titanium alloy. The fastening flange 431 has a central orifice433 which is sized to accommodate the exterior diameter of the graftvessel 254. The fastening flange 431 has an annular distal ridge 434 andan annular proximal ridge 435 around its outer surface. There are aplurality of holes 436 arranged in a circle around the periphery of thecentral orifice 433 of the flange 431 passing through the flange 431from the proximal surface to the distal surface 438, each of the holes436 is sized to slidably receive one of the S-shaped staple members 432.There are a plurality of cylindrical lugs 439 extending from theproximal surface 437 of the flange 431. Preferably, the lugs 439 arearranged in a circle concentric with the central orifice 433 and thereare an equal number of lugs 439 to the number of holes 436 in the flange431 with the lugs 439 spaced equidistant from adjacent holes 436.

[0191] The S-shaped superelastic alloy staple members 432 are shown inperspective FIG. 33D. The staple member 432 is formed with a straightcentral segment 440 that is attached to a hook-shaped distal segment 441and a proximal segment 442 which bends at an angle just under 90 degreesfrom the central segment 440 in a plane that is approximately at a rightangle to the plane defined by the hook-shaped distal segment 441. Thedistal tip 443 of the hook-shaped distal segment 441 is sharpened toeasily penetrate the graft vessel wall 254 and the target vessel wall255. FIG. 34D shows a slight variation of the staple member 432 of FIG.33D. This variation differs from the previous one in that the distalsegment 444 is bent at an acute angle to the central segment rather thanbeing a fully formed hook. The S-shaped staples 432 are annealed in thedesired configuration so that they will retain the annealed shape. Theextremely resilient nature of the superelastic alloy allows the staplemembers 432 to be completely straightened without causing plasticdeformation of the staples so that they will return to their annealedshape.

[0192] The anastomosis device 430 is prepared for use by passing thegraft vessel 254 through the central orifice 433 of the fastening flange431 then everting the distal end 259 of the graft vessel 254 over thedistal surface 437 of the flange 431. A suture 445 can be tied aroundthe everted end 259 of the graft vessel 254 to secure it to the flange431. The distal ridge 434 of the flange 431 prevents the tied graftvessel 259 from slipping off of the flange 431. Next, the staple members432 are straightened and passed through the holes 436 in the flange 431from the proximal surface 437 to the distal surface 438. The distalcurve 441 of the staples 432 is restrained in the straightened positionby the sliding fit with the holes 436 in the flange 431. When thestaples 432 emerge from the distal surface 438 of the flange 431, theypierce the everted wall 259 of the graft vessel 254. At this point thefastening flange 431 with the everted end 259 of graft vessel 254attached to it is approximated to the exterior surface 258 of the targetvessel 255 with the central orifice 433 and the lumen 249 of the graftvessel 254 centered on an opening 267 that has been made in the wall ofthe target vessel 255. The distal ends 443 of the staple members 432pass through the opening 267 in the target vessel wall 255.

[0193] Once the graft vessel 254 and the target vessel 255 are properlyapproximated, an annular staple driver 446 is used to push the staplemembers 432 distally through the holes 436 in the flange 431 so thatthey emerge into the lumen 256 of the target vessel 255. As the distalends 443 of the staple members 431 emerge from the distal surface 438 ofthe flange 431 the distal segments 441 resume their annealed shape. Thehook-shaped distal segments 441 of the staple members 431 in FIG. 33Dcurve back toward the interior surface 257 of the target vessel andpenetrate the target vessel wall 255. The proximal segments 442 of thestaple members 432 are positioned between the lugs 439 on the proximalsurface 437 of the flange 431 to lock the staples 432 from rotating withrespect to the flange 431. FIG. 33C shows a proximal view of theanastomosis device 430 with the staple members 432 deployed. This viewis shown without the graft vessel or the target vessel present for thesake of clarity. As best seen in FIG. 33B, the acute angle of theproximal segment 442 acts like a spring to pull back on the staplemember 432 to help the distal segment 441 to pierce the target vesselwall 255 and to help create compression between the flange 431 and thetarget vessel wall 255 to create a leak proof anastomotic seal betweenthe graft vessel 254 and the target vessel 255.

[0194] The deployment of the anastomosis device in FIGS. 34A-34D isessentially the same as just described up until the point when thedistal ends 444 of the staple members 432 begin to emerge into thetarget vessel lumen 256. As the distal ends 443 of the staple members432 emerge from the distal surface 438 of the fastening flange 431, theyresume their acute angle bend. Rather than penetrating the target vesselwall 255, the distal segments 444 of the staple member 432 alignthemselves flat against the interior surface 257 of the target vessel255 and press against the vessel wall 255, compressively clamping thefastening flange 431 and the everted end 259 of the graft vessel 254 tothe target vessel wall 255. The acute angle of the proximal segment 442acts like a spring to pull back on the staple member 432 to keep thedistal segment 444 snug against the interior surface 257 of the targetvessel wall 255.

[0195] FIGS. 35A-35F show another variation of an anastomosis device 447using a fastening flange 448 and attachment staple 449 combination. Thefastening flange 448 is a cylindrical member with an internal lumen 450large enough to accommodate the external diameter of the graft vessel254. The flange 448 has a distal surface 451 over which the free end 254of the graft vessel 259 may be everted. An annular ridge 452 around theouter surface of the flange 448 at the distal end helps to hold theeverted graft vessel 259 in place and serves as part of a lockingmechanism for the attachment staples 449, as will be described below.The attachment staples 449 are in the form of U-shaped hooks with barbedpoints 453 on their distal tips, each staple 449 has a proximal portion454 which is slidably received within an axial hole 456 through thecylindrical wall 457 of the fastening flange 448. The proximal end 455of the proximal portion 454 is sharpened for easily piercing the tissueof the graft vessel wall 254. A U-shaped bend 458 connects the proximalportion 454 of the staple 449 to the barbed, pointed distal portion 453.

[0196] The anastomosis device 447 is applied by removing the U-shapedstaples 449 from the flange 448. The end 259 of the graft vessel 254 ispassed through the internal lumen 450 of the flange 448 until the graftvessel 254 extends a short distance from the distal end 459 of theflange 448. Then, the end 259 of the graft vessel 254 is everted backover the distal end 259 of the flange 448. Once the graft vessel 254 iseverted over the flange 448, the staples 449 are reinserted into theholes 456 in the flange 458 by piercing the proximal end 445 through theeverted wall 259 of the graft vessel 254. Marks or other visualindications can be provided on the side of the cylindrical flange 448 toaid in aligning the proximal ends 455 of the staples 449 with the holes456. The proximal portions 454 of the staples 449 are partially advancedinto the flange 448 as shown in FIG. 35B. The U-shaped ends 458 of thestaples 449 are inserted through an opening, 267 in the wall of thetarget vessel 255 which has previously been made using a vessel punch orsimilar instrument. Two alternate methods can be used for inserting thestaples 449 through the opening 267 in the target vessel wall 255. Inthe first method, shown in FIG. 35C, the U-shaped ends 458 of thestaples are extended from the cylindrical flange 448 far enough thatthey easily deflect inward toward the center of the opening 267 in thetarget vessel wall 255 when they contact the edge of the opening 267 sothat they can be simultaneously inserted through the opening 267. In thesecond method, the U-shaped ends 458 of the staples 449 are rotated, asshown in FIG. 35D, so that the U-shaped ends 458 all fit within a circlethat will pass through the opening 267 in the target vessel wall 255.Once the U-shaped ends 458 of the staples 449 are within the lumen 256of the target vessel 255, the staples 449 can be rotated so that theU-shaped ends 458 extend radially outward from the fastening flange 448.The distal surface 459 of the cylindrical flange 448 with the evertedgraft vessel 259 attached to it is approximated to the exterior surface258 of the target vessel 255, then the staples 449 are withdrawn in theproximal direction so that the barbed, pointed distal ends 453 piercethe target vessel wall 255. The distal portion 460 of the staple 449passes through the target vessel 255 wall in a linear path, then piercesthe everted edge 259 of the graft vessel wall 254 a second time. Whenthe barbed end 453 of staples 449 pass the annular ridge 452 on thedistal end 459 of the flange 448 the barbs 453 engage the proximalsurface of the ridge 452, locking the staples 448 in position topermanently attach the anastomotic device 447 in place. The excesslength on the proximal portion 454 of the U-shaped staples 449 may becut off flush with the proximal end 461 of the cylindrical flange 448.Alternatively, the proximal portion 454 of the staple 449 can be bentover at the proximal end 461 of the cylindrical flange 448 for a secondmeans of attachment. then the excess length cut off.

[0197] Two alternative versions of the anastomosis device of FIG. 35A.using different locking means for the U-shaped staples, are shown inFIGS. 36A-36C and 37A-37C. FIG. 36A shows an anastomosis device 462 witha fastening flange 463 and a plurality of non-barbed U-shaped staples464 and a locking collar 465 for locking the U-shaped staples 464 ontothe fastening flange 463. The flange 463 and the staples 464 are appliedin much the same way as described above for the previous embodiment, byinserting the staples 464 through the opening 267 in the target vessel255 and withdrawing them in the proximal direction so that the distalends 466 of the staples 464 pierce the target vessel wall 255 and emergealongside the outer surface of the fastening flange 463. A lockingcollar 465 is then pressed onto the proximal end 467 of the fasteningflange 463, as shown in FIG. 36B, crimping the distal ends 466 of thestaples 464 and locking them to the flange 463 in the process. Theexcess length of the proximal portion 468 of the staples 464 is cut offflush with the proximal end 467 of the fastening flange 463 to completethe anastomosis, as shown in FIG. 36C.

[0198]FIG. 37A shows a second anastomosis fitting 469 with non-barbedU-shaped staples 470 and a locking collar 471 for locking the U-shapedstaples onto the fastening flange 472 of the fitting 469. The fasteningflange 472 in this embodiment has a conical surface 473 on the outersurface of the flange 472 proximal to the distal rim 474 of the flange472. The proximal end 475 of the fastening flange 472 has a series ofparallel annular locking ridges 476 around its exterior surface. Alocking collar 471 has an interior taper 477 which matches the conicaltaper 473 of the fastening flange 472 and a series of parallel lockingridges 478 on the proximal end. After the flange 472 and the staples 470have been applied as described above, the locking collar 471 is pressedonto the flange 472, as in FIG. 37B. The distal portion 479 of theU-shaped staple 470 is wedged between the mating conical tapers 473,477. The locking ridges 478 of the locking collar 471 engage the lockingridges 476 of the flange 472 to permanently lock the anastomosis device469 in place and the anastomosis is completed by cutting off theproximal portions 480 of the staples 470 flush with the proximal end ofthe flange 475, as shown in FIG. 37C.

[0199] The anastomosis fittings of FIGS. 33-37 may also be manufacturedusing staple elements made of a highly elastic material, such as asuperelastic nickel-titanium alloy, so that the staples may be preformedwith U-shaped ends which can be straightened and loaded into the holesin the fastening flange. The staples would be deployed by pushing themout the distal end of the flange so that they pass through the wall ofthe graft vessel into the target vessel, after which, they resume theirU shape within the lumen of the target vessel. The highly elastic stapleelements could be locked onto the fastening flange using any of themethods described in connection with FIGS. 33-37.

[0200] FIGS. 38A-38C and 39A-39C show one-piece versions of ananastomosis device using a fastening flange and attachment staplecombination. FIG. 38A shows an anastomosis device 481 that has afastening flange 482 and integrally formed staple members 483. Thefastening flange 482 is a flat annular ring which may be formed from aflat sheet of a biocompatible metal. The staple members 483, which maybe formed from the same sheet of metal, attach to the inner diameter 484of the ring 482 and are initially bent 90° from the flange 482 so thatthey extend in the distal direction, as shown in FIG. 38B. The innerdiameter 484 of the flange fits over a tubular inner member 485 of anapplication tool 486. The graft vessel 254 is passed through an innerlumen 487 within the tubular member 485 and then the end 259 of thegraft vessel 254 is everted over the distal end 488 of the tubularmember 485. The application tool 486 is used to approximate the end 259of the graft vessel 254 to an opening 267 that has previously been madein the wall of the target vessel 255. A tubular staple driver 489 slidestelescopically over the exterior of the tubular inner member 485. Thefastening flange 482 is moved distally by sliding the staple driver 489axially with respect to the inner tubular member 485, which forces thesharpened distal ends 490 of the integral staple legs 483 through theeverted wall 259 of the graft vessel 254 and the wall of the targetvessel 255. Once the staple legs 483 have traversed the graft vessel 254and target vessel walls 255, the distal ends 490 of the staple legs 483are deformed to lock the anastomosis device 481 in place as shown inFIG. 38C.

[0201] Different methods can be used for deforming the distal ends 490of the staple legs 483 to attach the anastomosis device 481. Anarticulating anvil, similar to the one described in FIG. 31A can beinserted through the lumen 249 of the graft vessel 254 to workcooperatively with the staple driver 489 to deform the distal ends 490of the staple legs 483. Alternatively, the fastening flange 482 and thestaple legs 483 can be made of a spring-like elastic or superelasticalloy and preformed into their final desired shape. The inner tubularmember 485 of the staple application device 486 seen in FIG. 38B holdsthe preformed distal bend 491 in the staple legs 483 straight until theanastomosis device 481 is deployed by the staple driver 489. Anotheralternative is to make the anastomosis device 481 and the staple legs483 from a shape-memory alloy, such as a nickel-titanium. The staplelegs 483 are annealed in their final shape. Then, the staple legs 483are plastically deformed below the material's transition temperature tostraighten out the distal bends 491. The straightened staple legs 483are driven through the walls of the graft vessel 254 and the targetvessel 255 and the staple legs 483 are heated above their shape-memorytransition temperature to make them resume their annealed shape. Thematerial is preferably chosen so that the transition temperature is ator near body temperature so that heating the staple above the transitiontemperature does not cause damage to the delicate vascular tissues.

[0202]FIG. 39A shows an additional anastomosis device 492 that has afastening flange 493 and integrally formed staple members 494. Thefastening flange 493 in this case is a cylindrical ring formed from atube of a biocompatible metal. The staple members 494 are attached tothe distal edge of the cylindrical fastening flange 493. Optionally,there are also proximal fastening members attached to the proximal edgeof the cylindrical fastening flange 493. This variation of theanastomosis device can be applied with any of the methods just describedin connection with FIGS. 37A-37C. If the anastomosis device 492 has beenmade of an elastic or superelastic alloy, the optional proximalfastening members 495 can serve as spring members to compress theanastomotic attachment, similar to the proximal portions of thespring-like staples 411, 420 described in connection with FIGS. 32A-32F.

[0203] FIGS. 40A-40D show a two-piece version of an anastomosis device496 having a fastening flange and integrally formed staple members. Inthis case, the fastening flange of the device is formed of twoconcentric cylindrical flange rings 497, 498. A plurality ofinterlocking staple members 499, 500 extend from the distal edges ofboth cylindrical flange rings 497, 498. Preferably, the staple members499, 500 are integrally formed with the cylindrical flange rings 497,498. The staple members 499 of the inner flange ring 497 are angled sothat they spiral downward from the ring 497 in a clockwise direction.The staple members 500 of the outer flange ring 498 are oppositelyangled so that they spiral downward from the ring 497 in acounterclockwise direction. Corresponding locking features 501, 502 onthe inner surface of the outer flange ring 498 and on the outer surfaceof the inner flange ring 497 are capable of locking the two flange rings498, 497 together in a fixed position. Indentations on one flange ring,with corresponding detents on the other flange ring are one of the manypossibilities for the locking features 501, 502.

[0204] The anastomosis device 496 is applied by separately placing firstthe outer flange ring 498, then the inner flange ring 497 around thedistal end 259 of the graft vessel 254. The end 259 of the graft vessel254 is then everted and approximated to the exterior wall 258 of thetarget vessel 255 surrounding an opening 267 which has been previouslymade in the wall, as shown in FIG. 40C. The inner ring 497 is moveddistally along the graft vessel 497 until the points of the staplemembers 499 contact the everted vessel wall 259. The inner ring 497 ispressed into the everted graft vessel wall 259 and simultaneouslyrotated in a clockwise direction, thereby driving the staple members 497through the graft vessel wall 259 and the target vessel wall 255. Next,the outer ring 498 is moved distally along the graft vessel 254 until itis concentric with the inner ring 497. Then the outer ring 498 ispressed into the everted graft vessel wall 259 and simultaneouslyrotated in a counterclockwise direction, driving the staple members 500through the graft vessel wall 259 and the target vessel wall 255. Whenthe locking features 501 of the outer ring 498 coincide with the lockingfeatures 502 of the inner ring 497, the outer 498 and inner 497 ringsbecome locked together. As the flange rings 497, 498 are rotated inopposite directions, the staple members 499, 500 of the inner 497 andouter rings 498 penetrate the vessel walls in opposite directions asshown in FIG. 40C, effectively locking the anastomosis device 496 to theexterior 258 of the target vessel 255.

[0205] Alternatively, the inner 497 and outer rings 498 of the flangecan be applied simultaneously to the everted end 259 of the graft vessel254 by arranging the rings 497, 498 concentrically, then pressing thestaple members 499, 500 into the graft vessel wall 259 whilecounter-rotating the inner 497 and outer 498 rings. This could best bedone with an instrument that holds and rotates the inner 497 and outer498 rings mechanically.

[0206] FIGS. 41A-41E show another approach to making an anastomosisdevice 503 having a fastening flange 504 and a plurality of individualstaple members 505. The method of deployment used in this embodimentallows the staple members 505 to be made of a normally elastic metalalloy, such as spring-tempered stainless steel. The fastening flange 504in this embodiment is a tubular element with a central orifice 506 whichis surrounded by an inner wall 507, a distal surface 508, and an outerwall 509 defining an annular space 510 between the inner 507 and outerwalls 509. The annular distal surface interconnects the inner 507 andouter 509 walls. The annular space 510 is sized to fit the staplemembers 505 prior to deployment, as shown in FIG. 41A. A stapleapplication tool 511 has an annular staple driver 512 which fits intothe annular space 510 within the flange 504. The distal surface 508 andthe inner wall 507 of the flange 504 is slotted with pairs of L-shapedslots 513 to allow penetration of the staple members 505 through thedistal surface 508.

[0207] Alternatively, the flange 504 may have a solid body and theannular space 510 can be replaced by a series of individual staple slotsformed in the body of the flange by a process like electrical dischargemachining. The individual staple slots can each be sized to fit a singlestaple member 505, each individual staple slot should communicate with asingle slot or a pair of slots in the distal surface 508 of thefastening flange 504 for proper deployment of the staple members 505,depending on whether the staple members are single or double-legstaples. In this case, the annular staple driver 512 of the applicationtool 511 must be replaced with an array of individual staple driverssized to fit into the individual staple slots.

[0208] The staple members 505 for this embodiment can be made asJ-shaped, single-leg staples 505′ or as U-shaped, double-leg staples505. When viewed from the side, the single 505′ and double-leg staples505 are both roughly the shape of an inverted J, as seen in FIG. 41A.The double-leg staples 505 combine two such J-shaped staple legs 514with a crossbar 515 that connects the proximal ends of the staple legs514 to form staples 505 that are roughly U-shaped when viewed from thefront or from the top, as in FIG. 41E. The staple legs 514 are formedwith a central segment 516 that is attached at an acute angle to aproximal segment 517. A short intermediate segment 518 may be used toconnect the proximal segment 517 to the central segment 516 of thestaple member 505. The proximal end of each of the proximal segments 517is joined to the crossbar 515 of the staple member 505. A distal segment519 is attached to the central segment 516 at an obtuse angle so that itis approximately parallel to the proximal segment 517. The distal end520 of the distal segment 519 is sharpened to easily penetrate the graftvessel wall 259.

[0209] The anastomosis device 503 is prepared by passing the graftvessel 254 through the central orifice 506 of the fastening flange 504and everting it over the distal surface 508 of the flange 504. As analternative to the loop of suture described in previous embodiments ofthe device, a vessel cap 521 may be used to secure the everted graftvessel 259 to the fastening flange 509. The vessel cap 521 is a toroidalring with an L-shaped cross section that fits around the outer diameterof the distal surface 508 of the fastening flange 504 and holds theeverted end 259 of the graft vessel 254 in place.

[0210] Next, the fastening flange 504 with the everted end 259 of thegraft vessel 254 attached is approximated to the exterior 258 of thetarget vessel 255 with the central orifice 506 aligned with an opening267 through the target vessel wall 255, as shown in FIG. 41A. The stapledriver 512 is then advanced in the distal direction to press against theattachment legs 514 of the staple members 505 and force the distal ends520 of the staple members 505 through the slots 513 in the distal end508 of the fastening flange 504 to pierce the graft vessel wall 259 andenter the target vessel lumen 256 through the opening 267 in the targetvessel wall 255, as shown in FIG. 41B. As the staple driver 512 isadvanced further the crossbar 515 of the staple member 505 contacts thedistal wall 508 of the fastening flange 504 and the staple member 505begins to rotate about the point of contact, as shown in FIG. 41C. Thedistal segments 519 of the staple members 505 capture the target vesselwall 255 and pull it tight against the distal surface 508 of thefastening flange 504, as shown in FIG. 41D, to form a leak proofanastomotic seal between the everted graft vessel wall 259 and thetarget vessel 255.

[0211] FIGS. 42A-42D illustrate another one-piece embodiment of theanastomosis device 522 with a fastening flange 523 and attached staplemembers 524. Preferably, the anastomosis device 522 is made from adeformable biocompatible metal, such as a stainless steel alloy, atitanium alloy or a cobalt alloy. If desired a surface coating can beapplied to the anastomosis device to improve the biocompatibility orother material characteristics.

[0212] In contrast to some of the previously described embodiments, inthis version of the anastomosis device 522, the fastening flange 523resides on the interior surface 258, of the target vessel wall 255 whenthe anastomosis is completed. To avoid any problems with hemolysis,thrombogenesis or foreign body reactions, the total mass of thefastening flange 523 has been reduced to an absolute minimum to reducethe amount of foreign material within the target vessel lumen 256.

[0213] The fastening flange 523 is in the form of a wire ring 523 withan internal diameter which when fully extended is just slightly largerthan the diameter of the graft vessel 254 and of the opening 267 made inthe target vessel wall 255. Initially, the wire ring 523 has a rippledwave-like shape to reduce the diameter of the ring 523 so that it willeasily fit through the opening 267 in the target vessel wall 255. Aplurality of staple members 524 extend from the wire ring 523 in theproximal direction. In the illustrative embodiment shown in FIG. 42A,there are nine staple members attached to the wire ring fastening flange523. Other variations of the anastomosis device 522 might typically havefrom four to twelve staple members 524 depending on the size of thevessels to be joined and the security of attachment required in theparticular application. The staple members 524 can be formed integrallywith the wire ring fastening flange 523 or the staple members 524 couldbe attached to the ring 523 by welding or brazing methods. The proximalends 525 of the staple members 524 are sharpened to easily pierce thetarget vessel wall 255 and the craft vessel wall 259. Preferably. theproximal ends 525 of the staple members 524 have barbs 526 to improvethe security of the attachment when the device is deployed.

[0214] The anastomosis device 522 is prepared for use by mounting thedevice onto the distal end of a specially adapted application instrument527, as shown in FIG. 42B. The fastening flange 523 is mounted onto ananvil 528 attached to the distal end of the elongated shaft 531 of theapplication instrument 527. The staple members 524 are compressed inwardagainst a conical holder 529 attached to the instrument 527 justproximal to the anvil 528. The staple members 524 are held in thiscompressed position by a cap 530 which is slidably mounted on theelongated shaft 531. The cap 530 moves distally to cover the sharpened,barbed ends 525 of the staple members 524 and to hold them against theconical holder 529. The application instrument 527 is then insertedthrough the lumen 249 of the graft vessel 254. This can be done byinserting the instrument through the graft vessel lumen 249 from theproximal to the distal end of the graft vessel 254, or it can be done bybackloading the elongated shaft 531 of the instrument into the graftvessel lumen 249 from the distal end to the proximal end, whichever ismost convenient in the case. The anvil 528 and holder 529 on the distalend of the application instrument 527 with the anastomosis device 522attached is extended through the opening 267 into the lumen 256 of thetarget vessel 255.

[0215] Next, the distal end 259 of the graft vessel wall 254 is evertedagainst the exterior surface 258 of the target vessel wall 255 with thegraft vessel lumen 249 centered on the opening 267 in the target vesselwall 255. The cap 530 is withdrawn from the proximal ends 525 of thestaple members 524, allowing the staple members 524 to spring outward totheir uncompressed position shown by the phantom lines 524′ in FIG. 42B.The application instrument 527 is then drawn in the proximal directionso that the staple members 524′ pierce the target vessel wall 255surrounding the opening 267 and the everted end 259 of the graft vessel254.

[0216] The application instrument 527 has an annular staple former 532which surrounds the outside of the graft vessel 254. Some slightpressure on the everted graft vessel wall 259 from the annular stapleformer 532 during the piercing step assists in piercing the staplemembers 524′ through the graft vessel walls 259. Care should be takennot to apply too much pressure with the staple former 532 at this pointbecause the staple members 524′ could be prematurely deformed beforethey have fully traversed the vessel walls. If desired, an annularsurface made of a softer material, such as an elastomer, can be providedon the application instrument 527 to back up the vessel walls as thestaple members 524′ pierce through them.

[0217] Once the staple members 524 have fully traversed the targetvessel wall 255 and the graft vessel wall 259, as shown in FIG. 42C thestaple former 532 is brought down with greater force while supportingthe fastening flange 523 with the anvil 528. The staple members 524′ aredeformed outward, as shown by the phantom lines 524″, so that thesharpened, barbed ends 525 pierce back through the everted graft vesselwall 259 and into the target vessel wall 255 to form a permanentattachment. To complete the anastomosis, the anvil 528 is withdrawnthrough the graft vessel lumen 249. As the anvil 528 passes through thewire ring fastening flange 523, it straightens out the wave-like ripplesso that the wire ring 523 assumes its full uncompressed diameter, asshown in FIG. 42D. Alternatively the wire ring fastening flange 523 canbe made of a resilient material so that the flange 523 can be compressedand held in a rippled or folded position until it is released within thetarget vessel lumen 256, whereupon it will resume its full, expandeddiameter. Another alternative construction would be to make theanastomosis device of a shape-memory alloy so that the wire ringfastening flange 523 can be compressed and inserted through the openingin the target vessel 267, whereupon it would be returned to its fullexpanded diameter by heating the device 522 to a temperature above theshape-memory transition temperature.

[0218] FIGS. 43A-43B. 44A-44B, and 45A-45E show a complete system forcreating an end-to-side vascular anastomosis using an anastomosis device533 with a fastening flange 534 and a plurality of staple members 535made of a highly resilient or superelastic metal. The system includes aspecially adapted application instrument 536 for applying theanastomosis device 533. FIG. 43A shows a top view of the fasteningflange 534 of the anastomosis device 533. FIG. 43B shows the fasteningflange 534 of FIG. 43A in cross section from the side. The fasteningflange 534 is generally cylindrical in shape with a central orifice 537of sufficient diameter to accommodate the external diameter of the graftvessel 254. The wall 538 of the fastening flange has a plurality ofholes 539 extending from the proximal surface 540 of the flange to thedistal surface 541 of the flange. Preferably there are an even number ofholes 539, two for each of the staple members 535, which may number fromfour to twelve depending on the size of the vessels to be anastomosed.The illustrated embodiment has twelve holes 539 to accommodate sixstaple members 535. The holes 539 are preferably angled toward thecentral orifice 537 from the proximal end 540 to the distal end 541 sothat they exit the wall 538 of the flange 534 at the juncture of thedistal surface 541 of the flange and the internal surface of the centralorifice 537. In the illustrative embodiment shown in FIGS. 43A and 43Bthe holes 539 are angled at approximately 10 degrees to the longitudinalaxis of the flange 534. Other angles are also possible, from −10 to +20degrees from the longitudinal axis of the flange 534 The fasteningflange 534 has a circumferential notch 542 on the exterior of the flange534 close to the distal end 541 of the flange to aid in attachment ofthe graft vessel wall 254. There is also a circumferential ridge 543around the exterior of the fastening flange 534 proximal to the notch542 to assist in gripping the flange 534 for the operation of theapplication tool 536.

[0219]FIGS. 44A and 44B show the staple member 535 of the anastomosisdevice 533 in a front view and a side view. The staple members 535 arepreferably formed from wire made of a highly resilient biocompatiblemetal such as a spring-tempered alloy of stainless steel, titanium, orcobalt, or more preferably of a superelastic metal alloy, such as anickel-titanium alloy. The wire preferably has a diameter between 0.006and 0.025 inches, depending on the stiffness of the metal alloy chosen.Nickel-titanium wire with a diameter of 0.010 to 0.012 inches has beenfound to be very suitable for this application. The staple members 535are roughly an inverted U shape when viewed from the front with twoattachment legs 544 joined together at their proximal ends by a crossbar545, as shown in FIG. 44A. When viewed from the side as in FIG. 44B, thestaple members 535 are roughly J-shaped with the distal ends 546 of theattachment legs 544 curving back toward the proximal end of the staplemember 535.

[0220] Each of the J-shaped hooks 547 ends in a short straight section548 with a sharpened distal end 546 to easily penetrate the graft vessel259 and target vessel 255 walls. The staple members 535 should beannealed or cold worked in the illustrated configuration, whichevertreatment is most appropriate for the metal alloy chosen, so that thestaple member has a permanent elastic memory which makes it return tothe treated shape.

[0221] The holes 539 through the fastening flange 534 are sized so thatthere is a close sliding fit between the attachment legs 544 of thestaple members 535 and the interior of the holes 539. The anastomosisdevice 533 is prepared for use by inserting the two attachment legs 544of each staple member 535 into two adjacent holes 539 in the fasteningflange 534, until the curved distal portion 547 of the attachment legs544 are entirely within the holes 539. When inserting the staple members535, they should be oriented so that the curve of the distal ends 547 ofthe attachment leas 544 will be biased outward from the central orifice537 of the fastening flange 534 when extended distally from the holes539 in the flange 534. Because of the close sliding fit, the interiorwalls of the holes 539 constrain the curved distal ends 547 ofthe-attachment legs 544 in a straight position, as shown in FIG. 43B.The straight proximal portion 549 of the staple members 535 extendproximally from the proximal end 540 of the fastening flange 534 asshown.

[0222] The preparation of the anastomosis device 533 can also beaccomplished using the shape-memory property of a nickel-titanium alloy.The staple members 535 would be formed as shown in FIGS. 44A and 44B andannealed to create a shape-memory. The attachment legs 544 of the staplemembers 535 are then straightened by cold working them below thetransition temperature of the shape-memory alloy. In the straightenedcondition, the distal ends 547 of the attachment leas 544 are easilyinserted into the holes 539 in the fastening flange 534. Care must betaken to orient the staple members 535 so that the curve of the distalends 547 of the attachment legs 544 will be biased outward from thecentral orifice 537 of the fastening flange 534. Once all of the staplemembers 535 have been inserted into the holes 539 of the fasteningflange 534, the entire anastomosis device 533 can be warmed above thetransition temperature of the shape-memory alloy so that the distal ends547 of the attachment legs 544 will try to return to their curved shape.Being constrained by the interior walls of the holes 539, the attachmentlegs 544 will remain straight, but they will have an elastic memory thatwill cause them to resume their curved shape when they are released fromthe confinement of the holes 539.

[0223] With the anastomosis device 533 thus prepared, it is ready to beinserted into the application instrument 536 which is shown in FIGS.45A-45E. The application instrument 536 consists of two separate, butinteracting, mechanisms, a stapling mechanism 550 and a punchingmechanism 551. The punching mechanism 551 is sized to be slidinglyreceived within an internal lumen 552 of the stapling mechanism 550.Most of the parts of the application instrument 536. unless otherwisespecified, are preferably made of a high-strength, dimensionally stablepolymer material, such as acetal, ABS, HDPE, PTFE, etc. Alternatively,the application instrument 536 could be made from stainless, steel,titanium or other metals, if desired.

[0224] The stapling mechanism 550 has a generally cylindrical holder 553which has a proximal end 554 and a distal end 555, an internal lumen 556extends from the proximal end 554 to the distal end 555. The distal end555 of the holder 553 is adapted to hold the fastening flange 534 of theanastomosis device 533, a through hole 557 in the distal end of theholder 553 is sized to be a light press fit around the proximal end 540of the fastening flange 534. A counterbore 558 on the distal end of thethrough hole 557 fits the circumferential ridge 543 of the fasteningflange 534 to axially locate the fastening flange 534 with respect tothe holder 553, a staple driver 559, which is generally tubular inshape, is slidably received within the internal lumen 556 in the holder553. The staple driver 559 has a T-shaped handle 560 attached to itsproximal end for operating the stapling mechanism 550. The proximal endof the staple driver 559 has a short tubular extension 561 with acircumferential groove 562 around the exterior of the tubular extension561. The distal end has an annular staple driving surface 563.

[0225] To insert the anastomosis device 533 into the distal end of thestapling mechanism 550, the proximal ends 549 of the staple members 535must be flexed slightly toward the central axis of the fastening flange534 so that they will all fit through the through hole 557 on the distalend of the holder 553. Once the proximal ends 549 of the staple members535 have been inserted, the proximal end of the fastening flange 540 isinserted into the through hole 557 with the circumferential ridge 543seated into the counterbore 558.

[0226] The stapling mechanism 550 is now ready for attachment of thegraft vessel 254 to the fastening flange 534. To begin, the graft vessel254 is passed through the internal lumen 552 of the holder 553 and thestaple driver 559. This can be done by tying a suture around one end ofthe graft vessel 254, passing the suture through the stapling mechanism550 and drawing the graft vessel 254 through. Alternatively, anelongated hook or grasping instrument can be inserted through the lumen552 of the stapling mechanism 550 to draw the graft vessel 254 through.The distal end 259 of the graft vessel 254 is then everted over thedistal end 541 of the fastening flange 534. If desired, a loop of suture564 can be tied around the everted end 259 of the graft vessel 254 atthe location of the circumferential notch or groove 542 to secure thegraft 259 to the fastening flange 534. The proximal end 565 of the graftvessel 254 can also be everted and temporarily attached with a loop ofsuture to the proximal extension 561 of the staple driver 559 to makethe graft vessel 254 easier to handle.

[0227] At this point, the vessel punch mechanism 551 should be insertedinto the stapling mechanism 550 through the lumen 249 of the graftvessel 254. The vessel punch mechanism 551 consists of a housing 566, acutter 567, an anvil 568, a clamp 569, a clamp knob 570 and a punch knob571. The housing 566 is generally cylindrical in shape. There are twoinner chambers 572, 573 in the housing which are separated by aninternal wall 574. The distal chamber 572 is sized to have a light pressfit over the holder 553 of the stapling mechanism 550. A pair of setscrews 575 in the side wall 576 of the distal chamber 572 are providedto secure the housing 566 to the holder 553. The side wall 576 of thedistal chamber 572 has pair of opposing open-ended slots 577 that aresized to fit over the T-shaped handle 560 of the staple driver 559 andallow the handle 560 to move axially within the slots 577. The proximalchamber 573 has an internal thread 579 that matches an external thread579 on the clamp knob 570. A counterbored hole 580 through the internalwall 574 connects the proximal 573 and distal 522 chambers.

[0228] The cutter 567 of the vessel punch mechanism 551 is a longslender tubular member which is preferably made of a hardenable alloy ofstainless steel. The distal end 581 of the cutter 567 is slightlyenlarged with respect to the shaft 582 of the cutter 567, and there is acounterbore 583 within the enlarged distal end 581. The distal edge ofthe cutter 567 has a sharp, beveled cutting edge 584. Preferably, atleast the cutting edge 584 of the tubular cutter 567 is hardened. Theproximal end of the cutter shaft 582 has a snug press fit into thecounter hole 580 through the internal wall 574 of the housing 566. Thepunch mechanism 551 also includes a clamp 569. The clamp 569 has a longtubular shaft 585 which is sized to be slidably received within theinternal lumen 586 of the cutter shaft 582. An enlarged head 587 on thedistal end of the shaft 585 is sized to fit within the counterbore 583in the distal end of the cutter 567. The distal end of the enlarged head587 has an annular clamping surface 588. The proximal end of the clampshaft 585 is inserted into the cutter 567 and glued or otherwisefastened to the clamp knob 570 which is threaded into the proximalchamber 573 of the housing 566. The anvil 568 of the punch mechanism 551is preferably made of stainless steel. The anvil 568 has an elongatedshaft 589 that has a sliding fit with the internal lumen 590 of theclamp 569. An enlarged head 591 on the distal end of the shaft 589 issized to fit within the counterbored distal end 583 of the cutter with avery close clearance between the head of the anvil 591 and the cutter567. The proximal end of the shaft 589 is threaded to attach it to thepunch knob 571. The punch knob 571 has a distal extension 592 which isthreaded to fit into a threaded hole 593 on the proximal end of theclamp knob 570.

[0229] When the clamp knob 570 is rotated with respect to the housing566, the clamp 569 is advanced proximally or distally with respect tothe cutter 567. In its farthest distal position. the clamping surface588 of the clamp 569 is just distal to the cutting edge 584 of thetubular cutter 567. When the punch knob 571 is rotated with respect tothe clamp knob 570, the anvil 568 is advanced proximally or distallywith respect to the clamp 569. By moving the anvil 568 proximally withrespect to the clamp 569 when the clamp is in its farthest distalposition. the tissue of the target vessel wall can be clamped betweenthe clamp and the anvil. When the clamp knob 255 and the punch knob 571are rotated in unison, the anvil 568 and the clamp 569 can be withdrawninto the tubular cutter 567 to effect the cutting action of the punchmechanism 551. Preferably, the clamp 569, the anvil 568 and the tubularcutter 567 are keyed to one another or otherwise rotationally fixed sothat they move axially with respect to one another without relativerotation.

[0230] The punch mechanism 551, as it has just been described, isinserted into the stapling mechanism 550 through the lumen 249 of thegraft vessel 254. The clamp 569 of the punch mechanism 551 should beadvanced to its farthest distal position before inserting the punch 551through the graft vessel 254 to avoid damaging the interior wall of thecraft vessel 254 with the cutter 567 as it passes through. The setscrews 575 in the housing 566 of the punch mechanism 551 are screwedinto corresponding holes 594 in the holder 553 of the stapling mechanism550 to secure the two interacting mechanisms together. The graft vessel254 occupies an annular space 595 between the punch mechanism 551 andthe interior surface of the stapling mechanism 550. Thus assembled, theanastomosis system, which includes the anastomosis device 533 attachedto the graft vessel 254 and the application instrument 536, is preparedto perform an end-to-side anastomosis between the graft vessel 254 and atarget vessel 255.

[0231] The operation of the application instrument 536 is illustrated inFIGS. 45A-45E, a slit 596 is made in the wall of the target vessel 255with a scalpel or other sharp instrument. If it has not been donealready, the clamp 569 of the punch mechanism 551 is advanced distallyby turning the clamp knob 570 until the clamp surface 588 extendsslightly beyond the cutting edge 584 of the cutter 567, and the anvil568 of the punch mechanism 551 is advanced distally by turning the punchknob 571 until the anvil head 591 extends distally from the applicationinstrument 536. The anvil head 591 of the punch mechanism 551 isinserted through the slit 596 into the lumen 256 of the target vessel255, and the distal edge 541 of the fastening flange 534 with theeverted end 259 of the graft vessel 254 attached is approximated to theexterior surface 258 of the target vessel 255, as shown in FIG. 45A. Thetarget vessel wall 255 is then clamped by the punch mechanism 551 byturning the punch knob 571 to move the anvil head 591 proximally untilthe target vessel wall 255 is firmly gripped between the anvil head 591and the clamp surface 588, as shown in FIG. 45B. The clamp feature ofthe punch mechanism 551 prevents the cutter 567 from prematurely cuttingthrough the wall of the target vessel 255 and it provides a firm supportto the target vessel wall 255 for the stapling step which follows.

[0232] If the anastomosis system is being used to create a proximalanastomosis between a graft vessel and the aorta during a CABGprocedure, the clamping feature provides an additional benefit at thispoint in the procedure. In order to reduce the crossclamp time that thepatient is subjected to, many cardiac surgeons prefer to perform theproximal anastomosis while the patient's heart is still beating. Thisrequires isolating a portion of the aortic wall with a nonoccludingside-biting clamp to prevent excessive bleeding from the opening formedin the aorta. This has a number of disadvantages: 1) even a nonoccludingside-biting clamp presents additional resistance to aortic blood flow,possibly reducing cardiac output which may already be low, 2) theside-biting clamp tends to distort the aortic wall, making it harder tocreate a neat anastomosis, 3) conventional side-biting clamps aredifficult to apply in a closed-chest or port-access thoracoscopic CABGprocedure, and 4) side-biting clamps may break atherosclerotic tissueloose from the inner wall of the aorta, possibly causing strokes orother complications. The clamping feature reduces the need for theside-biting clamp by clamping directly to the aortic wall around theslit made by the scalpel for inserting the anvil. This creates afluid-tight seal preventing bleeding through the aortotomy opening, sothat the side-biting clamp can be released and removed from the site. Itis also possible to avoid the need for the side-biting clamp entirely byquickly inserting the anvil head 591 of the punch mechanism 551 andtightening the clamp 569 immediately after creating the aortotomy slitbefore significant blood loss can occur. If the head of the anvil 591were made with a blade or trocar extending from its distal surface, thedevice 536 could pierce and dilate an opening in the aorta wall in thesame motion as inserting the anvil 591 through the opening, potentiallysaving time and blood loss.

[0233] In the stapling step, the staple driver 559 is advanced distallyby pressing on the T25 shaped handle 560, as shown by arrows 597 in FIG.45C. This causes the distal end 563 of the staple driver 559 to pressagainst the crossbars 545 of the staple members 535 and forces theattachment legs 544 to exit through the holes 539 in the distal end 541of the fastening flange 534. As the attachment legs 544 emerge from theholes 539, the sharpened distal ends 546 of the attachment legs 544pierce the graft vessel wall 259 and the short straight section 548traverses the graft vessel wall 259 in a linear path. Optionally, thestaples 535 can be advanced through the graft vessel wall 259 before thegraft vessel 259 is approximated to the target vessel 255 so that thesurgeon can verify that all of the staple attachment legs 544 haveproperly pierced the everted graft vessel wall 259. The sharpened distalends 546 of the attachment legs 544 then pierce the target vessel wall255. The clamping feature 569 of the punch mechanism 551 supports thetarget vessel wall 255 and keeps it closely approximated to the evertedend 259 of the graft vessel 254 as the staple members 535 penetrate it.As the attachment legs 544 penetrate the target vessel wall 255, thecurved sections 547 of the attachment legs 544 emerge from theconfinement of the holes 539 in the fastening flange 534 and the elasticmemory of the unrestrained curve causes the attachment legs 544 to takea curved path outwardly from the central orifice 537 through the targetvessel wall 255. The distal ends 547 of the attachment legs 544 resumetheir J shape, as shown in FIG. 45C, firmly attaching the fasteningflange 534 and the everted graft vessel 259 to the exterior surface 258of the target vessel 255.

[0234] Once the fastening flange 534 and the graft vessel 254 areattached, an opening 267 is made in the target vessel wall 255 byturning the clamp knob 570 and punch knob 571 in unison to withdraw theanvil 568 and the clamp 569, with the target vessel wall 255 grippedbetween them, into the tubular cutter 567, as shown in FIG. 45D. Thisaction shears off a small, circular portion of the target vessel wall255 to form a fluid communication between the lumen 256 of the targetvessel 255 and the lumen 249 of the graft vessel 254. To complete theanastomosis, the fastening flange 534 is released from the holder 553and the punch mechanism 551 and the entire application instrument 536are withdrawn, as shown in FIG. 45E.

[0235] FIGS. 46A-46D illustrate a second embodiment of the anastomosissystem using an anastomosis device 600 with an inner fastening flange601, an outer flange 602 and staple members 603 made of a superelasticnickel-titanium alloy. The system includes a stapling mechanism 604 forattaching the anastomosis device 600 to the wall of the target vessel255 through a previously made opening 267. The anastomosis device 600has a fastening flange 605, which is shown in top view in FIG. 46C andin side cross section views in FIGS. 46A and 46B. The fastening flange605 includes a tubular body 606 which has an internal lumen 607 ofsufficient diameter to accommodate the external diameter of the graftvessel 254. Attached to the distal end of the tubular body 606 is aninner flange 601 over which the free end 259 of the graft vessel 254will be everted. On the proximal end 610 of the tubular body 606 arethree radially extending lugs 608, which facilitate grasping theanastomosis device 600 while performing the anastomosis. The exterior ofthe tubular body 606 has an external step 609 so that it is slightlylarger in diameter at its proximal end 610 than at its distal end 611.The interior of the tubular body 606 has an internal step 612 so thatthe internal diameter of the tubular body is slightly smaller at thedistal end 610 than at the proximal end 611, a plurality of holes 613pass through the fastening flange 605 from the internal step 612 to thedistal surface 611 of the inner flange 601. The holes 613 are arrangedin pairs, six pairs in this illustrative example, to accommodate a likenumber of staple members 603.

[0236] An outer flange 602 is concentrically located on the tubular body606. The outer flange 602 is attached to the tubular body 606 by aself-locking ring washer 614 which has inclined lugs 615 which allow thering washer 614 to slide distally with respect to the tubular body 606,but which prevent it from sliding proximally. The ring washer 614 can bemade integrally with the outer flange 602 or a separate sheet metal ringwasher 614 can be attached to the outer flange 602, as illustrated. Theinternal orifice 616 of the ring washer 614 and the outer flange 602 ismade with three wide slots 617 between the inclined lugs 615 to allowthem to be placed onto the tubular body 606 over the lugs 615 whichextend from the proximal end 610 of the tubular body 606. The outerflange 602 has a distal surface 618 which is slightly concave. Theperipheral edge 619 of the outer flange 602 has six notches 620 cut intoit which coincide with the location of the distal ends 621 of the staplemembers 603 after they are deployed, as shown in FIG. 46C.

[0237] The staple members 603 are generally an inverted U shape whenviewed from the front as in FIG. 46D. Two attachment legs 622 are joinedtogether at their proximal ends by a crossbar 623. Viewed from the sideas in FIG. 46B, the staple members are somewhat J-shaped with thesharpened distal ends 624 curving back in the proximal direction. Thestaple members 603 are preferably formed from wire made of a highlyresilient biocompatible metal such as a spring-tempered alloy ofstainless steel, titanium, or cobalt, or more preferably of asuperelastic metal alloy, such as a nickel-titanium alloy.

[0238] For clarity only the distal end of the stapling mechanism 604 hasbeen shown in FIG. 46A. Suitable handle means are provided at theproximal end for actuating the stapling mechanism 604. The staplingmechanism 604 has an outer sleeve 625, which is a tubular member havingthree L-shaped fingers 626 extending from its distal end that grasp theradially extending lugs 615 on the proximal end of the tubular body 606like a bayonet connector. The clamp sleeve 627 is a tubular member whichslides telescopically over the exterior of the outer sleeve 625. Astaple guide 628 resides within the outer sleeve 625. The staple guide628 is a tubular member having a plurality of slots 629, equal to thenumber of staple members 603 in the anastomosis device, extendingthrough the wall from the proximal end to the distal end of the guide628. The slots 629 in the guide 628 are sized to fit the staple members603 therein and to constrain the J-shaped attachment legs 622 of thestaple members 603 in a straight position prior to deployment, as shownin FIG. 46A. The staple guide 628 can be made by cutting a plurality ofslots 629 through the wall of the tubular member with electricaldischarge machining, or the staple guide 628 can be made from twoclosely fitting concentric tubes by cutting slots like splines in theexternal surface of the inner tube and sliding the outer tube over it toclose the slots. The staple driver 630 is a tubular member which isslidably received within the outer sleeve 625. A plurality of fingers631 extend from the distal end of the staple driver 630. The fingers 631of the staple driver 630 are sized to be slidably received within theslots 629 of the staple guide 628.

[0239] The anastomosis device 600 is prepared by inserting the staplemembers 603 into the slots 629 in the staple guide 628 in the staplingmechanism 604. The staple guide 628 holds the staple members 603 in astraightened position within the stapling mechanism 604. The fasteningflange 605 is inserted into the stapling mechanism 604 and the radiallyextending lugs 608 are grasped by the L-shaped fingers 626 of the outersleeve 625. The staple holes 613 through the tubular body 606 arecarefully aligned with the distal ends 621 of the staple members 603 andthe staple driver 630 is advanced slightly to start the staple members603 into the holes 613. The anastomosis device 600 is now prepared toperform an end-to-side anastomosis between a graft vessel 254 and thewall of a target vessel 255 as follows.

[0240] To begin, the graft vessel 254 is inserted through the centrallumen 607 of the fastening flange 605 and the internal lumen 632 of thestapling mechanism 604 by drawing it through with a suture or anelongated grasping instrument. The distal end 259 of the graft vessel254 is then everted over the inner flange 601 on the distal end 611 ofthe fastening flange 605. The inner flange 601 with the everted end 259of the graft vessel 254 attached is inserted through an opening 267 inthe target vessel wall 255 that has previously been made using an aorticpunch or similar instrument. The staple driver 630 is advanced distally,causing the sharpened ends 621 of the staple members 603 to pierce theeverted wall 259 of the graft vessel 254 and enter the lumen 256 of thetarget vessel 256, as the staple members 603 emerge from the distal end611 of the fastening flange 605, the attachment legs 622 resume theirJ-shaped curve and penetrate the interior surface 257 of the targetvessel wall 255, as shown in FIG. 46D. Once the staple members 603 arecompletely deployed, the clamp sleeve 627 is advanced distally withrespect to the outer sleeve 625, which forces the outer flange 602 tomove in the distal direction with respect to the tubular body 606. Asthe outer flange 602 moves distally, the inner flange 601 and the targetvessel wall 255 are pulled into the concave distal surface 618 of theouter flange 602 to form a smooth, hemodynamically efficient connectionbetween the lumen 256 of the target vessel 255 and the lumen 249 of thegraft vessel 254. The stapling mechanism 604 is now removed by rotatingthe outer sleeve 625 to release its grasp on the tubular body 606 andwithdrawing the entire stapling mechanism 604. It should be noted thatthe embodiment of FIG. 46, like the embodiment of FIG. 43, couldoptionally be manufactured without an inner flange 601, whereby theinner wall 257 of the target vessel 255 is supported by the staplemembers 603 themselves.

[0241] FIGS. 47A-47B. 48A-48B, and 49A-49C show an anastomosis stapledevice 635 which combines a plurality of precurved inner staple members636 of a highly resilient material with a plurality of deformable outerattachment legs 637. FIGS. 47A-47B show a top view and a side crosssection view of the anastomosis staple in an undeployed state. FIGS.47A-47B show a top view and a side cross section view of the anastomosisstaple in a deployed state. FIGS. 49A-49C show the sequence ofoperations for deploying the anastomosis staple device. As shown inFIGS. 47A-47C, the device 635 has a ring-shaped bushing 638 with aninternal diameter 639 of sufficient size to accommodate the exteriordiameter of the graft vessel 254. A plurality of deformable attachmentlegs 637, six in this exemplary embodiment, are attached to the proximalend of the ring-shaped bushing 638. The deformable attachment legs 637are preferably made of a metal which can be plastically deformed andwhich will maintain its final deformed shape, such as stainless steel ora titanium alloy. The attachment legs 637 can be machined integrallywith the ring-shaped bushing 638 as shown, or the attachment legs 637can be made separately, for instance by stamping, electrical dischargemachining or die cutting a ring of attachment legs 637 from sheet metal,and fastening the attachment legs 637 to the ring-shaped bushing 638.The attachment legs 637 are typically 0.012 inches thick, 0.040 incheswide and 0.230 inches long. The thickness and width of the attachmentlegs can vary somewhat depending on the stiffness of the material chosenfor the attachment legs 637. It may be desirable to radius the edges ofthe attachment legs 637 or to make the attachment legs 637 round incross section in order to reduce the potential for initiating cracks ortears in the target vessel wall 255. The length of the attachment legs637 can be varied to accommodate different wall thicknesses of the graftvessels 254 and target vessels 255 to be attached.

[0242] The attachment legs 637 are typically formed flat, then bent orstamped into a curved configuration as shown in FIGS. 47B. The distalportion 640 of each attachment leg 637 is curved in a circular arc whosecenter coincides approximately with the point of attachment 641 betweenthe attachment leg 637 and the ring-shaped bushing 638. The attachmentpoint 641 serves as the bending fulcrum for the attachment legs 637 whenthey are deformed during the anastomosis procedure. The intermediateportion 642 of the attachment legs 637 can be left relatively straight,or an intermediate curve 642 can be formed in the attachment legs 637,as shown in FIG. 47B. The distal ends 643 of the attachment legs 637 aresharpened so that they will easily penetrate the target vessel walls255.

[0243] The ring-shaped bushing 638 has a distal surface 644 over whichthe end 259 of the graft vessel 254 will be everted. The distal end 644of the ring-shaped bushing 638 is flared out slightly to provide a moresecure attachment of the everted end 259 of the graft vessel 254 to thebushing 638. There are a plurality of axial holes 645 in the wall of thering-shaped bushing 638 which communicate with the distal surface 644 ofthe bushing 638. The holes 645 are sized to have a close sliding,clearance with the legs 646 of the inner staple members 636. Preferably,the axial holes 645 are arranged in pairs to accommodate both legs ofU-shaped inner staple members 636, as shown in FIG. 47A, the currentlypreferred embodiment has six pairs of axial holes 645 for six U-shapedinner staple members 636. The axial holes 645 are angled outwardslightly, typically by about 10 degrees, from the central axis of thering-shaped bushing 638. Angling the axial holes 645 outward tends toreduce the distance from the distal surface 644 of the bushing 638 tothe bottom of the curve of the staple members 636 once the staplemembers 636 have been deployed. There are also a plurality of transverseholes 647 through the wall of the ring-shaped bushing 638 to facilitategripping the bushing 638 with the staple application instrument 648.

[0244] The staple members 636 are generally an inverted U shape whenviewed from the front as in FIG. 47A. Two staple legs 646 are joinedtogether at their proximal ends by a crossbar 649. Viewed from the sideas in FIG. 48B, the deployed staple members 636 are somewhat J-shapedwith the sharpened distal ends 650 curving back approximately 180degrees in the proximal direction. The staple members 636 are preferablyformed from wire made of a highly resilient biocompatible metal such asa spring-tempered alloy of stainless steel, titanium, or cobalt, or morepreferably of a superelastic metal alloy, such as a nickel-titaniumalloy. The anastomosis staple device 635 is prepared for use byinserting the curved distal ends 651 of the J-shaped staples into theaxial holes 645 in the ring-shaped bushing 638. The internal walls ofthe axial holes 645 hold the curved ends 651 of the staple members 636in a straightened position within the ring-shaped bushing 638.

[0245] The anastomosis staple of FIGS. 47A-47B and 48A-48B is part of acomplete anastomosis system which includes a specialized stapleapplication instrument 648 for performing the anastomosis procedure. Thestaple application instrument 648 is shown in FIGS. 50A-50B. As seen inFIG. 50B, the instrument 648 has a gripper 652 which is adapted to holdthe ring-shaped bushing 638 of the staple device. The gripper 652 is agenerally tubular member that has a plurality of gripping fingers 653extending axially from its distal end, each of the gripping fingers 653has an inwardly turned distal tip 654 which is sized to fit into one ofthe transverse holes 647 in the ring-shaped bushing 638. The grippingfingers 653 are spring-biased outward. A combination gripper actuatorand outer attachment leg driver 655 is slidably received on the exteriorof the gripper shaft 656. The actuator/driver 655 is generally tubularin shape, having a lumen 657 with a close sliding fit over the exteriorof the gripper 652 and a radiused annular staple driving surface 658 onits distal end. When the actuator/driver 655 is slid distally over theexterior of the gripping fingers 653, the outwardly biased fingers 653are pressed inward so that they grip the ring-shaped bushing 638 byengaging the transverse holes 647.

[0246] An inner staple driver 659 is slidably received within the innerlumen 661 of the tubular shaft 656 of the gripper 652. The inner stapledriver 659 has an annular staple driving surface 660 on its distal end.The inner staple driver 659 has an internal lumen 662 that canaccommodate the graft vessel 254 during the anastomosis procedure. Thegripper 652, the actuator/driver 655 and the inner staple driver 659 areheld together by a pair of alignment pins 663 which are threaded intothe wall of the actuator/driver 655. The gripper shaft 656 has a pair ofopposing axial slots 664 that allow it to slide axially with respect tothe actuator/driver 655. The inner staple driver 659 has a pair ofopposing L-shaped slots 665 oriented to allow the inner staple driver659 to slide axially with respect to the gripper 652 and theactuator/driver 655. The inner staple driver 659 can be moved to alocked position to prevent premature activation of the inner staples 636by withdrawing it distally and rotating it so that the alignment pins663 enter the L-shaped portion 666 of the slots 665.

[0247] In preparation for the anastomosis procedure, the proximal end ofthe ring-shaped bushing 638, with the proximal ends of the inner staples636 extending from it, is inserted into the gripper 652 with thetransverse holes 647 aligned with the ends 654 of the gripping fingers653. The inner staple driver 659 should be withdrawn to the lockedposition before the staple device 648 is inserted. The actuator/driver655 is advanced distally, causing the ends 654 of the gripping fingers653 to flex inward and engage the transverse holes 647 in thering-shaped bushing 638. The actuator driver 655 can be advanceddistally until it rests against, but does not deform, the attachment leg637 of the staple device 635.

[0248] At this point the graft vessel 254 is passed through the internallumen 662 of the staple applying instrument 648 until a short length ofthe graft 254 extends from the distal end of the instrument 635. The end259 of the graft 254 is then everted over the distal surface 644 of thering-shaped bushing 638. If desired, a loop of suture can be tied aroundthe everted end 259 of the graft vessel 254 to secure it to the bushing638. The staple instrument 635, with the everted end 259 of the draftvessel 254 attached, is approximated to the exterior surface 258 of thetarget vessel 255 where an opening 267 in the target vessel wall 255 haspreviously been made with a vessel punch or similar instrument. If theanastomosis is part of a port-access CABG procedure, the instrument 635is inserted into the chest of the patient through an access port made inone of the intercostal spaces.

[0249] The ring-shaped bushing 638 is inserted into the opening 267 inthe target vessel wall 255 to approximate the intimal surface on theeverted end 259 of the graft vessel 254 with the intimal surface 257 ofthe target vessel 255, as shown in FIG. 49A. Preferably, the opening 267in the wall of the target vessel 255 is made slightly smaller than theouter diameter of the ring-shaped bushing 638 so that there is somecompression around the bushing 638 which helps to seal the anastomosisagainst leakage. The inner staple driver 659 is rotated to release itfrom the locked position and advanced distally to drive the inner staplemembers 636 through the everted wall 259 of the graft vessel 254, as thestaple members 636 exit the axial holes 645 in the bushing 638, theyresume their J-shaped curve 651 so that they curve back distally andpenetrate the interior surface 257 of the target vessel wall 255, asshown in FIG. 49B. After the inner staple members 636 have beendeployed, a light tension is exerted on the staple applying instrument648 to make sure that the inner staple members 636 are well seated andthe actuator/driver 655 is advanced distally to deform the outerattachment legs 637. The sharpened distal ends 643 of the attachmentlegs 637 penetrate the exterior 258 of the target vessel wall 255 in acircular arc, gathering the tissue and compressing it against theexterior of the ring-shaped bushing 638 and the everted edge 259 of thegraft vessel 254 to form a leak-proof anastomotic seal, as shown in FIG.49C. The actuator/driver 655 is withdrawn in the proximal direction,thereby releasing the ring-shaped bushing 638 from the gripper 652, andthe entire staple applying instrument 648 is withdrawn from theanastomosis site.

[0250]FIG. 51 shows an additional feature which can be used with any ofthe anastomosis devices described above. This feature is a combinationstrain relief and compliance mismatch transition sleeve 667. One of thecurrent theories about long-term patency and the causes of restenosis inbypass grafts proposes that the mismatch in vessel compliance betweenthe target vessels, which include the aorta and the coronary arteries,and the graft vessel, typically a saphenous vein, can contribute to thedevelopment of intimal hyperplasia, stenosis and occlusion in the graftvessel, especially at the anastomosis where the compliance mismatch ismost apparent. Joining a highly compliant vessel, such as a saphenousvein, to a relatively noncompliant vessel, like the aortic wall, placesextra strain on the vessels and on the anastomosis, another cause formismatched compliance at an anastomosis site is the joining of acompliant blood vessel with a highly noncompliant artificial graftvessel, additionally. turbulence in the blood flow at the anastomosissite may exacerbate the problem, accelerating the stenosis process. Itis preferable that all of the vessels be equally compliant or at leastthat there is a gradual transition in compliance from one vessel toanother. As such, it would be desirable to provide the anastomosisdevices with a means to create a gradual transition in compliancebetween the vessels at the anastomosis site.

[0251] Another concern in anastomosis procedures is to create a gradualcurve in the graft vessel leading away from the anastomosis site. Thisis sometimes necessary because the most convenient angle for attachingthe graft vessel to the target vessel does not match the desired pathfor the graft vessel away from the anastomosis. For instance, in CABGsurgery the desired path for the graft vessel is often parallel to theascending aorta, however the graft vessel must be joined to theascending aorta at some angle in order to create the anastomosis.

[0252] Creating a gradual curve leading away from the anastomosis siteto avoid kinking or narrowing of the graft vessel lumen is sometimesproblematic. This is especially true when the graft vessel is joined atright angles to the ascending aorta. It would be desirable therefore toprovide the anastomosis devices with a reliable means to create agradual curve in the graft vessel leading away from the anastomosissite.

[0253] The combination strain relief and compliance mismatch transitionsleeve 667 is a flexible tubular member 668 which can be appended to theproximal end of the anastomosis device 669 to support the graft vessel254 leading away from the anastomosis site. The flexible tubular member668 may have any or all of gradually decreasing stiffness, increasingcompliance and increasing diameter as it extends proximally from theanastomosis device 669. This will give the graft vessel 254 a gradualcurve, a gradual change in its radial compliance, and a gradual changein diameter from the constrained diameter within the anastomosis device669 to an unconstrained diameter some distance from the device 669.

[0254] The strain relief sleeve 667 can be made in any one of severalpossible constructions, including braided wire or monofilament, a wireor plastic coil, a solid polymer tube or a composite construction, suchas a wire coil embedded in a polymer wall. The strain relief sleeve 667may also be made of a soft, stretchy, biocompatible polymer, such aspolyurethane, silicone, or Gortex (expanded PTFE).

[0255]FIG. 52 shows a device 670 for isolating a portion of the targetvessel lumen 256 to facilitate performing an anastomosis using any ofthe devices and techniques described herein. The isolation device 670may be used as an alternative to the side-biting clamp described abovefor use in the proximal anastomosis procedure during CABG surgery. Theside-biting clamp is used in CABG surgery to isolate a portion of theaortic wall so that the proximal anastomosis can be performed while theheart is still beating without excessive bleeding at the anastomosissite. Placing a side-biting clamp thoracoscopically during port-accessCABG surgery may prove problematic. A perfusion endoaortic clampcatheter 670, as shown in FIG. 52, performs the same functions as theside-biting clamp with a percutaneously placed catheter. The catheter670 has a first doughnut-shaped balloon 671 and a second doughnut-shapedballoon 672 which are interconnected by a large-bore perfusion tube 673.The balloons 671, 672 and the perfusion tube 673 are mounted on thedistal end of an elongated catheter shaft 674. The balloons 671, 672 andthe perfusion tube 673 are preferably made of a semi-elasticpolyurethane material so that it can be collapsed for percutaneous entryand so it will resume the appropriate shape when they are deployed. Thecatheter shaft 674 may have a single inflation lumen 675 which connectsto both balloons 671, 672 or separate inflation lumens connected to eachballoon. If desired, the catheter 670 may also be provided with aflushing lumen which connects to a flushing port located on the exteriorof the perfusion tube 673 between the balloons 671, 672 for flushing theanastomosis site 678 with clear saline to improve visibility.

[0256] In operation, the balloons 671, 672 and the perfusion tube 673are introduced percutaneously into a peripheral artery, such as thefemoral artery and advance into the ascending aorta 676, preferablyunder fluoroscopic visualization. When the surgeon is prepared to makethe aortotomy incision to start the proximal anastomosis procedure, thefirst and second balloons 671, 672 are inflated, isolating the portionsof the aortic wall 677 between the two balloons 671, 672 from the bloodflow in the aorta. Blood continues to flow through the large-boreperfusion tube 673, supplying the rest of the body with blood. With theaortic wall 677 isolated, the aortotomy incision can be made at theanastomosis site 678 and the anastomosis completed by any of the methodsdescribed in the specification, after the anastomosis is complete, theballoons 671, 672 are deflated and the catheter is withdrawn from theaorta 676.

[0257] This catheter approach has certain advantages over the use of aside-biting clamp. First, it isolates a larger portion of the aorticwall so that the surgeon has more choice in the placement of theanastomotic sites. Second, because it isolates a larger portion of theaortic wall it also allows multiple anastomoses to be made to the aortawithout having to move the clamp. Third, it does not distort the wall ofthe aorta as the side-biting clamp does. This may allow more accurateplacement of the anastomotic sites and more effective attachment of theanastomosis devices and therefore reduced leakage of the anastomoses.

[0258] A second, smaller scale version of a similar catheter device 679is shown in FIG. 53 for isolating a section of a coronary artery 682while performing a distal anastomosis. This device would allow thesection of the coronary artery 682 close to the anastomosis to beisolated from the blood flow without blocking blood flow to vitalmyocardium downstream of the anastomosis site. The availability of rapidand reliable anastomosis devices, such as those described herein, couldopen the door to performing CABG surgery on patients whose hearts arestill beating, with no need at all for cardioplegic arrest. The rapidityof the anastomosis procedure using these devices will minimize theinterference from the wall motion of the beating heart that makes handsutured anastomoses problematic. However, two other obstacles remain: 1)excessive bleeding at the anastomotic site when the coronary artery isincised, and 2) temporary ischemia of the myocardial tissue downstreamof the anastomosis site. The catheter 679 in FIG. 53 solves both ofthese potential problems. The distal end of the catheter has a distalballoon 680 and a proximal balloon 681 separated by a few centimetersdistance along the catheter shaft 683. The balloons 680, 681 may beelastic balloons made of latex, polyurethane or silicone, or they may beinelastic balloons made of polyethylene, polyester or polyamide. Thecatheter shaft 683 may have a single inflation lumen 648 which connectsto both balloons 680, 681 or separate inflation lumens connected to eachballoon. If desired, the catheter 679 may also be provided with aflushing lumen which connects to a flushing port located on the cathetershaft 683 between the balloons 680, 681 for flushing the anastomosissite 690 with clear saline to improve visibility. In addition, thecatheter shaft 683 has a perfusion lumen 685 for blood flow through thecatheter 679. The perfusion lumen 685 has one or more inflow ports 686on the catheter shaft 683 proximal to both of the balloons 680, 681 andat least one outflow port 687 at the end of the catheter 679, distal toboth of the balloons 680, 681.

[0259] In operation, the catheter 679 is introduced into the coronaryartery 682 through a coronary guiding catheter 688 which is preferablyintroduced percutaneously from the femoral or brachial artery. Thedistal balloon 680 is advanced past the stenosis 689 in the artery 682,preferably under fluoroscopic visualization, and placed distal to thedesired anastomosis site 690. The proximal balloon 681 is placedproximal to the desired anastomosis site 690 at a point which may beproximal or distal to the stenosis 689. The inflow ports 686 of theperfusion lumen 685, however, should be located proximal to the stenosis689. The proximal 681 and distal 680 balloons are inflated to isolatethe area between them from the blood flow through the coronary artery682. Blood continues to flow into the artery distal to the catheter 679through the perfusion lumen 685. The distal anastomosis procedure cannow be performed on the isolated section of the coronary artery. Whenthe anastomosis is complete, the balloons 680, 681 are deflated and thecatheter 679 is withdrawn.

[0260] A third catheter device 691 is shown in FIG. 54. This catheterdevice 691 is configured to be delivered to the anastomosis site throughthe lumen 249 of the graft vessel 254 which has a number of potentialadvantages. First, the device 691 can be used without the need for afemoral or brachial artery puncture or a coronary guiding catheter todeliver the catheter 691 into the coronary arteries 682. Second, thecatheter 691 can be deployed under direct or endoscopic visualization bythe surgeon without the need for fluoroscopic imaging. Third, theT-shaped configuration of the catheter 691 can help to facilitateapproximation of the graft vessel 254 and the target vessel 255 duringthe anastomosis procedure.

[0261] The catheter 691 has a proximal catheter body 692 connected to aT-shaped distal portion 693. The T-shaped distal portion 693 has twodistal ends 694, 695, each having an inflatable balloon 696, 697 at itsdistal extremity. The balloons 696, 697 are each connected to one ormore inflation lumens 698 that terminate in a luer fitting at theproximal extremity of the proximal catheter body 692, a perfusion lumen699 connects a separate luer fitting at the proximal extremity of theproximal catheter body 692 to the extremities of both distal ends 694,695 of the catheter 691, distal to the inflatable balloons 696, 697.

[0262] In operation, the T-shaped distal end 693 of the catheter ispassed through the lumen 249 of the graft vessel 254 with the balloons696, 697 deflated, an incision 700 is made in the wall of the coronaryartery 682 or other vessel at the desired anastomosis site and bothdistal ends 694, 695 of catheter 691 are introduced into the coronaryartery 682 through the incision 700. One distal end 695 of the catheter691 is directed upstream of the anastomosis site and the other distalend 694 is directed downstream of the anastomosis site. Both of theballoons 696, 697 are inflated to isolate the portion of the coronaryartery 682 between the balloons 696, 697 from the blood flow in theartery. Two modes of perfusion are possible with the catheter 691. Ifthe upstream end 695 of the distal portion 693 of the catheter 691receives enough blood flow, the blood will pass through the perfusionlumen 699 from the upstream side 695 to the downstream side 694 toperfuse the coronary artery 682 distal to the anastomosis site 700. Ifthe blood flow is insufficient because of a severe stenosis or totalocclusion upstream of the anastomosis site 700, blood and/orcardioplegic fluid can be injected into the catheter 691 through theluer fitting connected to the perfusion lumen 699 at the proximal end ofthe catheter 691.

[0263] With the anastomosis site 700 isolated from the blood flow, thegraft vessel 254 can be approximated to the target vessel with theT-shaped catheter body 693 providing a guide for the approximation. Theanastomosis can be performed in a blood-free environment using any oneof the devices and methods described above. When the anastomosis iscomplete, the balloons 696, 697 can be deflated and the catheterwithdrawn through the lumen 249 of the graft vessel 254. The catheterdevices described above are not limited in their use to CABG surgery.

[0264] Either of the catheter devices could easily be modified to be theappropriate size for use during other bypass operations such asaorto-femoral bypass or femoral-femoral bypass.

[0265] Port-Access CABG Procedure

[0266] A vascular anastomosis procedure using the devices and methods ofthe present invention will now be described in relation to performing aproximal anastomosis on a free graft during a closed-chest orport-access coronary artery bypass graft surgical procedure.

[0267] Closed-chest or port-access coronary artery bypass graft (CABG)surgery is a newly developed procedure designed to reduce the morbidityof CABG surgery as compared to the standard open-chest CABG procedure.The morbidity is reduced in the port-access CABG procedure by gainingaccess to the heart and the coronary arteries through one or more accessports which are made in the intercostal spaces of the patient's chest,thereby eliminating the need for a median stemotomy or other grossthoracotomy as is required in open-chest CABG surgery. A port-accesscoronary artery bypass graft surgical procedure using suturedanastomosis techniques is more fully described in co-pending patentapplications, Ser. Nos. 08/023,778 and 08/281,891, which have beenincorporated herein by reference.

[0268] To prepare the patient for the port-access CABG procedure, thepatient is placed under general anesthesia and cardiopulmonary bypass(CPB) is established to support the patient's circulatory system duringthe surgical procedure. Preferably, a femoral-to-femoral CPB system isused to reduce the invasive nature of the procedure. One or more accessports 702 are made through the intercostal spaces 703 of the patient'schest by making an incision between the ribs 705 and placing a trocarwith a cannula 704 through the wall of the chest. The trocar is thenwithdrawn, leaving the cannula 704 as an access port into the chestcavity. Typically, an endoscope, preferably a thoracoscopic surgicalmicroscope, is placed through one of the access ports to allow directvisualization of the heart, the ascending aorta and the coronaryarteries.

[0269] Meanwhile a graft vessel is prepared for creating the bypassgraft which will redirect blood flow from the ascending aorta to one ormore of the coronary arteries downstream of any blockage caused byatherosclerotic disease. Vessels which can be used as free grafts inCABG surgery include veins, such as the saphenous vein, arteries, suchas one of the internal mammary arteries or the gastro-epiploic artery,and artificial grafts, such as Dacron or Goretex (expanded PTFE) grafts.If an autologous graft, such as a vein or an artery, is to be used, thevessel is generally harvested from the patient at this time.

[0270] Depending on the preference of the surgeon, the proximalanastomosis, which joins the graft vessel to the aorta, can be performedbefore or after the distal anastomosis, which joins the graft vessel toone or more of the coronary arteries. The distal anastomosis isgenerally performed while the patient's heart is stopped, whereas theproximal anastomosis may be performed with the heart stopped or whilethe heart is still beating, according to the preferences of the surgeon.To stop the heart, a special endo-aortic clamping catheter, which isdescribed in the aforementioned patent applications, is inserted intothe ascending aorta via a percutaneous entry or a surgical cutdown intothe femoral artery. An endo-aortic clamping balloon on the distal end ofthe catheter is inflated in the patient's ascending aorta to block bloodflow in the patient's aorta downstream of the coronary arteries.Cardioplegic solution is immediately infused into the patient's coronaryarteries through a lumen in the catheter to temporarily stop thepatient's heart from beating. Alternatively, the proximal anastomosiscan be performed while the heart is still beating by using a side-bitingclamp or other device to isolate a portion of the aortic wall from theaortic blood circulation. With a portion of the aortic wall isolatedfrom the systemic circulation by either of these methods, the proximalanastomosis can be performed using any of the devices and methodspreviously described herein.

[0271] The rapidity and reliability of performing the anastomoses usingthe devices and methods of the present invention may, in some instances,allow the entire coronary artery bypass procedure, including theproximal and distal anastomoses to be performed without the need forcardiopulmonary bypass support or cardioplegic arrest of the heart. Thiswould be of even greater benefit to the patient by further decreasingthe morbity from the procedure and reducing the likelihood of sideeffects associated with CPB and cardioplegia. It would also bebeneficial to the surgeon and the hospital by reducing the cost andcomplexity of the CABG procedure.

[0272] By way of example, the proximal anastomosis procedure will now bedescribed using the two-part anastomosis staple device 100 of FIG. 1, asmall incision 151 is made in the ascending aorta 707 at the anastomosissite 706 under endoscopic visualization. Then, the vessel punchmechanism 120 and the stapling mechanism 119 with the anchor member 101of the anastomosis staple, which have previously been prepared as shownin FIG. 2, are introduced through one of the intercostal access ports702 and positioned at the anastomosis site, as in FIG. 55. The anchormember 101 is attached to the ascending aorta 707 at the anastomosissite 706 according to the procedure in FIGS. 5A-5D, as follows. Theanvil 136 of the vessel punch 120 is inserted though the incision 151 inthe aortic wall 707, and the anchor member 101 is advanced distally sothat the attachment legs 105 penetrate the aortic wall 707.

[0273] Then, staple driver 127 is advanced to deform the attachment legs105 and fasten the anchor member 101 to the exterior wall of the aorta707. An opening 152 is then punched in the aortic Wall 707 with thevessel punch 120 and the punch 120 is removed along with the tissue 153excised by the punch. The graft insertion tool 121 and the graft vessel148, which has previously been prepared with the coupling member 102 asshown in FIG. 6 by everting the distal end of the graft vessel 148 overthe coupling member 102, are then inserted though the access port 702,as shown in FIG. 56, and the graft vessel 148 is attached to theascending aorta 707 at the anastomosis site 706 by inserting thecoupling member 102 into the anchor member 101 as shown in FIGS. 5F-5G.

[0274] The bypass operation is then completed by anastomosing the distalend 708 of the graft vessel to the coronary artery 709 below thestenosis or occlusion, as shown in FIG. 57. The distal anastomosis canbe performed using suturing techniques or the graft vessel 148 can bejoined to the coronary artery 709 using a second anastomosis staple byfollowing the steps shown in FIGS. 5A-5C and FIG. 7C, using theembodiment of the graft insertion tool 122 illustrated in FIGS. 7A-7C.

[0275] Alternatively, the proximal and distal anastomoses can beperformed in the reverse order, as is preferred by some cardiacsurgeons. In this case the distal anastomosis would be performed first,using the graft insertion tool 121 of FIGS. 6A-6C, followed by theproximal anastomosis performed using the graft insertion tool 122 ofFIGS. 7A-7C. When performing the proximal anastomosis as the secondanastomosis on a free graft, both ends of the graft vessel can beprepared for anastomosis by attaching a coupling member 102 to theproximal and the distal end of the graft vessel 148 and inserting thegraft vessel 148 into the chest cavity of the patient through one of theaccess ports 702 after attaching anchor members 101 to both the aorta707 and the coronary artery 709, each of the coupling members 102 canthen be inserted into its respective anchor member 101 using theappropriate insertion tool 121, 122. An alternate technique is to firstattach the distal end of the graft vessel 148 to a coronary artery 709using an anastomosis staple or sutures, according to the preference ofthe surgeon, then, after verifying the correct length of the craftvessel, drawing the proximal end 710 of the graft vessel 148 out of thechest cavity through one of the access ports 702. The free proximal end710 of the graft vessel 148 can be prepared under direct vision by thesurgeon by passing the free end of the graft vessel through the lumen ofthe coupling member 102 and everting it over the distal end 115 of thecoupling member 102. The coupling member 102 with the proximal end 710of the graft vessel attached can be reinserted into the chest cavitythrough the access port 702 and inserted into an anchor member 101attached to the aortic wall 707 using the graft insertion tool 122 ofFIGS. 7A-7C. This same technique can be used with the two-pieceanastomosis staple for performing a distal anastomosis on a pedicledgraft vessel or for performing a distal anastomosis on a free graftafter the proximal anastomosis has already been made.

[0276] The operation of the one-piece anastomosis staples of FIGS. 9,10, 11 or 12 can also be understood in relation to FIGS. 55-57. Thegraft vessel 148 and the one-piece anastomosis staple 163 are preparedas described above in relation to FIGS. 13 and 14, a small incision 151is made in the ascending aorta 707 with a sharp blade at the intendedanastomosis site 706, which has been isolated from the circulation witha side-biting clamp or other isolation device, an elongated punch, whichmay be similar to the vessel punch 120 described in relation to FIGS. 2and 5D above, is inserted through one of the access ports 702 in thepatient's chest. An opening 152 is made in the wall of the ascendingaorta 707 by inserting the anvil of the punch through the incision, thenpressing the actuating plunger to advance the tubular cutter over theanvil. The staple applying tool of FIG. 13 with the graft vessel 148everted over the distal tubular extension 166 of the anastomosis staple163, as shown in FIG. 14, is introduced through an access port 702 andpositioned near the punched hole 152 in the ascending aorta 707 asillustrated in FIG. 55. The flanged end 167 of the distal tubularextension 166 is passed through the hole 152 so that it is in theposition shown in FIG. 10.

[0277] The wall of the ascending aorta 707 stretches slightly to allowthe flange 167 to pass through the hole 152. The staple applying tool179 is pulled back slightly to make sure the flange 167 of the staple163 engages the interior wall of the aorta 707, then the lever 185 ofthe staple applying tool 179 is pulled to deform the attachment legs 168of the staple 163 and drive them through the aortic wall 707, as shownin FIG. 10. The lever 185 is released and the staple applying tool 179is rotated to disengage the staple retainer 188 from the tabs 170 on theproximal tubular extension 169 of the staple 163. The staple applyingtool 179 is withdrawn and the anastomosis is complete.

[0278] As with the two-piece embodiment of the anastomosis staple, theone-piece anastomosis staple of FIG. 9 can also be used for creating theproximal and/or distal anastomoses on a graft vessel in either order,according to the preference of the surgeon. When performing the secondanastomosis on a free graft or the distal anastomosis on a pedicledgraft, the free end of the graft vessel can be drawn out of the chestcavity through one of the access ports to prepare the end of the graftvessel under direct vision by the surgeon. The graft vessel is preparedby passing the free end of the graft vessel through the lumen of theanastomosis staple and everting it over the distal flange. Theanastomosis staple with the free end of the graft vessel attached can bereinserted into the chest cavity through the access port and attached tothe wall of the target vessel, which may be the ascending aorta or oneof the coronary arteries.

[0279] Although the foregoing description focuses on the use of theanastomosis system in closed-chest CABG surgery, the system is equallyapplicable to other situations that require vessel anastomosis,including, but not limited to renal artery bypass grafting,aorto-femoral bypass, femoral-femoral bypass and arterio-venousshunting, such as is commonly used for dialysis. Surgical anastomosesare also performed for various reasons on many different tubular organsof the body other than blood vessels, including the bowel, intestines,stomach and esophagus. While the devices and methods of the presentinvention are intended primarily for vascular anastomoses, some or allof the embodiments could also be modified for performing end-to-sideanastomoses on other tubular organs. Any one of the one or two-pieceembodiments of the anastomosis staple device can be supplied preattachedto a prosthetic graft vessel. For instance, the two-piece anastomosisstaple device could be supplied in a kit, including a natural orartificial graft that is prepared with a coupling member attached to oneor both ends and one or two anchor members for attachment to the targetvessel(s). Likewise, the one-piece anastomosis staple device can besupplied in a procedural kit preattached to a prosthetic graft vessel.This is equally applicable to artificial graft materials, such PTFE orDacron grafts, or to natural biological graft materials, includingallografts of human graft vessels, or xenografts such as bovine orporcine graft vessels, either freshly harvested, glutaraldehyde treatedor cryogenically preserved. An anastomotic device applicationinstrument, such as those described above, could also be supplied in theprocedural kit with one of the anastomotic devices already attached tothe distal end of the instrument.

[0280] While the above is a complete description of the preferredembodiments of the invention, various alternatives, modifications andequivalents may be used. Therefore, the above description should not betaken as limiting the scope of the invention, which is defined by theappended claims.

What is claimed is:
 1. An anastomosis staple device for connecting afree end of a graft vessel to a wall of a target vessel such that alumen in the graft vessel is in fluid communication with a lumen in thetarget vessel through an opening in the wall of the target vessel, theanastomosis staple device comprising: an anchor member, said anchormember having means for attaching said anchor member to said wall ofsaid target vessel, a coupling member, said coupling member beingconfigured to attach said free end of said graft vessel to said couplingmember, and a coupling means for attaching said coupling member to saidanchor member such that said end of said graft vessel is sealinglyconnected to said wall of said target vessel and said lumen of saidcraft vessel is in fluid communication with said lumen of said targetvessel through said opening in said wall of said target vessel.
 2. Ananastomosis fitting for connecting a free end of a graft vessel to awall of a target vessel such that a lumen in the graft vessel is influid communication with a lumen in the target vessel through an openingin the wall of the target vessel, the anastomosis fitting comprising: aninner flange, said inner flange having a proximal surface and a distalsurface and a central orifice of sufficient size to accommodate anexternal diameter of said graft vessel, said inner flange providing anatraumatic attachment for said end of said graft vessel when said end ofsaid graft vessel is passed through said central orifice and evertedover said inner flange, said inner flange being insertable through saidopening in said wall of said target vessel, an outer flange, said outerflange having a proximal surface and a distal surface and a centralorifice of sufficient size to accommodate the external diameter of saidgraft vessel, said distal surface of said outer flange being configuredto contact an exterior surface of said wall of said target vesselproximate said opening, and means for maintaining said outer flange in aselected position with respect to said inner flange such that saideverted end of said graft vessel is sealingly connected to said wall ofsaid target vessel and said lumen of said graft vessel is in fluidcommunication with said lumen of said target vessel through said openingin said wall of said target vessel.
 3. The anastomosis fitting of claim2, wherein said inner flange is configured such that the everted end ofsaid graft vessel substantially covers at least said distal surface ofsaid inner flange such that said inner flange is fluidly isolated fromsaid lumen of said target vessel and said lumen of said graft vessel. 4.The anastomosis fitting of claim 2, further comprising a tubular bodyhaving a proximal end and a distal end, said inner flange beingconnected to said distal end, said tubular body having a central lumenof sufficient size to accommodate an external diameter of said graftvessel.
 5. The anastomosis fitting of claim 4 wherein a proximal portionof said tubular body is configured to be slidably received in saidcentral orifice of said outer flange, and said means for maintainingsaid outer flange in a selected position with respect to said innerflange comprises a locking means for locking said outer flange to saidtubular body.
 6. The anastomosis fitting of claim 5 wherein said lockingmeans comprises a self-locking retaining washer slidably positioned onan exterior surface of said tubular body.
 7. The anastomosis fitting ofclaim 3 wherein said outer flange is deformable from an initialconfiguration wherein said distal surface of said outer flange does notcontact said exterior surface of said wall of said target vessel to adeployed configuration wherein said distal surface of said outer flangecontacts said exterior surface of said wall of said target vessel. 8.The anastomosis fitting of claim 2 wherein said means for maintainingsaid outer flange in a selected position with respect to said innerflange comprises a deformable means for connecting said outer flange tosaid inner flange, whereby said deformable means can be deformed toposition and hold said outer flange in a selected position with respectto said inner flange.
 9. The anastomosis fitting of claim 2 wherein saidouter flange is divided into a plurality of flange sectors, each of saidflange sectors being connected to said inner flange by way of at leastone deformable means.
 10. The anastomosis fitting of claim 9 whereinsaid deformable means is connected to said inner flange by way of atubular body, said tubular body having a central lumen of sufficientsize to accommodate an external diameter of said graft vessel.
 11. Theanastomosis fitting of claim 2 wherein said outer flange comprises atubular body connected to said inner flange, said tubular body beingdeformable from an undeformed configuration to an expanded configurationto form said outer flange.
 12. The anastomosis fitting of claim 11wherein said tubular body is divided into a plurality of longitudinalsegments, said longitudinal segments being predisposed to expand outwardwhen compressed axially.
 13. The anastomosis fitting of claim 2, whereinsaid inner flange has at least two operative positions, including: acollapsed position wherein said inner flange has a collapsed diameter,and an expanded position wherein said inner flange has an expandeddiameter which is greater than said collapsed diameter.
 14. Theanastomosis fitting of claim 13, wherein said inner flange comprises aplurality of flange sectors, said flange sectors being collapsed towardone another to occupy a diameter equal to said collapsed diameter whensaid inner flange is in said collapsed position, and said flange sectorsbeing expandable away from one another to occupy a diameter equal tosaid expanded diameter when said inner flange is in said expandedposition.
 15. The anastomosis fitting of claim 14, further comprising anexpansion means for expanding said inner flange from said collapsedposition to said expanded position.
 16. The anastomosis fitting of claim15, wherein said expansion means comprises a tubular member which, wheninserted into said central orifice between said flange sectors, forcessaid flange sectors from said collapsed position to said expandedposition.
 17. The anastomosis fitting of claim 2, wherein said innerflange comprises a plurality of initially longitudinally orientedsegments, said segments being configured to expand radially in responseto being compressed axially.
 18. The anastomosis fitting of claim 17,wherein said initially longitudinally oriented segments have a proximalend which is connected to said outer flange and a distal end, saidsegments being configured to expand radially when said distal end iscompressed axially toward said proximal end.
 19. The anastomosis fittingof claim 18, wherein said segments have a curved portion intermediatesaid proximal end and said distal end predisposing said segments toexpand radially when said distal end is compressed axially toward saidproximal end.
 20. A method of performing an anastomosis to connect afree end of a graft vessel to a wall of a target vessel such that alumen in the graft vessel is in fluid communication with a lumen in thetarget vessel through an opening in the wall of the target vessel, themethod comprising: attaching said free end of said graft vessel to aninner flange of an anastomotic fitting; inserting said inner flange withsaid free end of said graft vessel attached through said opening in saidwall of said target vessel and engaging an inner surface of said targetvessel with said inner flange; positioning an outer flange of saidanastomostic fitting in contact with an exterior surface of said wall ofsaid target vessel proximate said opening; and coupling said innerflange and said outer flange such that said graft vessel is sealinglyconnected to said wall of said target vessel and said lumen of saidgraft vessel is in fluid communication with said lumen of said targetvessel through said opening in said wall of said target vessel.